Northwestern University Feinberg School of Medicine
Department of Medicine
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Cardiology Clinical Trials

The following searchable list includes all the Division of Cardiology, Department of Medicine clinical trials currently looking for participants. Please feel free to contact us with inquiries about any of our ongoing research.

Trials
Iron Deficiency and FGF23 Regulation in Chronic Kidney Disease and Heart Failure
Our research group is currently conducting a 6-week iron deficiency anemia study on healthy individuals, individuals with CKD, and individuals with CHF to find out if treating iron deficiency anemia with intravenous iro…
Our research group is currently conducting a 6-week iron deficiency anemia study on healthy individuals, individuals with CKD, and individuals with CHF to find out if treating iron deficiency anemia with intravenous iron sucrose therapy can safely and successfully lower FGF23 levels. Iron sucrose has been shown to lower FGF23 in animal models. The short term effects of iron sucrose on FGF23 levels in CKD and CHF are not known. We are conducting this research study to understand the effects of intravenous iron sucrose therapy on blood levels of FGF23 in iron deficiency anemia in healthy individuals, individuals with CHF, individuals with CKD, and individuals with CKD and CHF. The information gained from this study could be used to improve the health of patients with iron deficiency anemia and disease of the kidneys and heart.
hemoglobin < 12, ferritin <100 or ferritin <300 w/ TSAT < 20, no active infections, no active use of immunosuppresants
Mehta, RupalMehta, Rupal
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT03106298 STU00201742
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Fox, Patrick 312 503 1887
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The Effect of KNO3 Compared to KCl on Oxygen Uptake in Heart Failure with Preserved Ejection Fraction
KNO3CK-OUT HFpEF: This study is enrolling participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF). This is a condition that causes patients to be short of breath and l…
KNO3CK-OUT HFpEF: This study is enrolling participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF). This is a condition that causes patients to be short of breath and limited in what they can do in their daily lives. Currently, there are no approved drugs for this condition. Researchers are trying to find new therapies for this condition. The purpose of this study is to test whether Potassium Nitrate (KNO3) will improve how people with HFpEF can exercise. In HFpEF, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. We do not know exactly why these limitations occur. There is some evidence that in addition to problems with the heart, patients with HFpEF also have problems with their arteries and muscles that affect their ability to exercise. Potassium Nitrate has been shown to improve how muscles work and also improve blood flow to working muscles in the body in healthy individuals. We previously conducted a pilot study with our KNO3 pills and found them to be safe in subjects with HFpEF. We would like to now study our pills in a large study to see if we can improve exercise in HFpEF. The use of Potassium Nitrate in this study is investigational. Potassium Nitrate has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study.
Shah, Sanjiv JShah, Sanjiv J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02840799 STU00202379
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Patel, Harnish H 312 695 4481
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Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life: A Multicenter Study
Ramp-It-Up: This study is enrolling patients with a recently implanted left ventricular assist device (LVAD) device. Patients with an LVAD undergo routine test…
Ramp-It-Up: This study is enrolling patients with a recently implanted left ventricular assist device (LVAD) device. Patients with an LVAD undergo routine testing to determine the best pumping speed for their LVAD that help guide medical treatment. One routine testing uses echocardiography (ultrasound of the heart) to create heart images and make measurements while gradually increasing the LVAD heart pump speed. Each time the pump speed is increased, images and measurements are taken. This is called a ramp test. The ramp testing may also be performed during a right heart catheterization procedure (insertion of a catheter into a vein or artery in the groin, arm or neck guided to the heart using X-ray imaging). Doctors normally perform this procedure to obtain hemodynamic measurements (measure the pressure and blood flow in the heart). If the ramp testing is performed during this procedure, then the doctors have additional measurements to consider before choosing a final speed for the LVAD pump. Both of these methods for determining pump speed are accepted as normal, routine care for LVAD patients. In this study participants will be randomly (by chance) assigned (1:1) evenly to one of these two methods of testing. The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo Ramp Tests to determine which method of testing provides better information for adjusting pump speed and medical treatment for LVAD patients. Better adjustments may provide better quality of life, exercise tolerance and reduced unwanted cardiac events over a 6-month period.
Rich, JonathanRich, Jonathan
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203630
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Crooke, Catherine 312 695 4189
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Exercise in Genetic Cardiovascular Conditions: Lifestyle and Exercise in Hypertrophic Cardiomyopathy: “LIVE-HCM”/ Lifestyle and Exercise in Long QT Syndrome: “LIVE-LQTS”
This research study will look at how lifestyle and exercise impact well-being in patients with HCM or LQTS. Participants w…
This research study will look at how lifestyle and exercise impact well-being in patients with HCM or LQTS. Participants will be asked to periodically wear pedometers, upload data to a secure website, and complete interviews and questionnaires via telephone or online for up to three years. We expect up to 50 people here will be in this research study out of 4286 people in the entire study nationally.
Choudhury, LubnaChoudhury, Lubna
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02549664 STU00204370
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Zinn, Sarah 312 926 2828
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A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (TH…
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. Participants in this study will have the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) to replace the failing bioprosthetic aortic valve access through the heart through a small incision is in the chest. The study device and its delivery system are investigational, which means they are not approved for commercial use by the U.S. Food and Drug Administration (FDA) for the valve in bioprosthetic valve procedure. The previous generation of SAPIEN valves, SAPIEN XT, was approved for commercial use by the FDA for a failed surgical bioprosthetic aortic valve in October 2015. The study device is a bioprosthetic heart valve made out of man-made materials and animal tissue. It is an artificial device made to replace the diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in the heart. Study participation will last approximately 10 years. Participants will be asked to come to clinic for study visits at 30 days, 6 months, and 12 months after the study procedure and then annually until 10 years after the procedure. We expect up to 19 people will be enrolled at Northwestern. The study expects to enroll up to 125 people internationally.
*Main Inclusion Criteria*
Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.

*Main Exclusion Criteria*
Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion).
Severe regurgitation (>3+) or stenosis of any other valve.
Failing valve is unstable, rocking, or not structurally intact.
Malaisrie, S Chris ChrisMalaisrie, S Chris Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03003299 STU00204739
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Duquette, Audrey 312 926 7078
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EFFECTS OF DAPAGLIFLOZIN ON BIOMARKERS, SYMPTOMS AND FUNCTIONAL STATUS IN PATIENTS WITH PRESERVED EJECTION FRACTION HEART FAILURE (PRESERVED-HF TRIAL)
This study is recruiting people who have Type 2 diabetes mellitus (T2DM) or prediabetes and heart failure (Inability of the heart to pump blood with …
This study is recruiting people who have Type 2 diabetes mellitus (T2DM) or prediabetes and heart failure (Inability of the heart to pump blood with normal efficiency). The purpose of the study is to find out if a drug called dapagliflozin would be effective in improving the blood tests and symptoms related to heart failure while also treating type 2 diabetes or potentially preventing type 2 diabetes if you have pre-diabetes. To do this, dapagliflozin will be compared with placebo. The placebo will look like dapagliflozin but is inactive. Dapagliflozin lowers glucose (sugar) levels in the blood by blocking the effect of specific molecules (small particles) called sodium-glucose transporters. Under normal circumstances, the sodium-glucose transporters in the kidney prevent glucose in the blood stream from leaving the body through urine. Dapagliflozin inhibits the sodium-glucose transporters and lowers blood glucose by allowing glucose removal through the urine. Dapagliflozin may also mildly decrease body weight and lower blood pressure in certain patients. Dapagliflozin is approved by the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes. Dapagliflozin is not specifically approved for the treatment of type 2 diabetes in people with heart failure and therefore its use in this study is investigational. We expect up to 20 people here will be in this research study out of 320 people in the entire study nationally..

  • Age > 18 and < 120 at the screening visit 
  • Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea 
  • Ejection fraction (EF) ≥ 45% as determined on imaging study within 24 months of enrolment with no change in clinical status suggesting potential for deterioration in systolic function 
  • Elevated NT-proBNP (≥ 225 pg/ml) or BNP (≥ 75 pg/ml) Ŧ 
  • Stable medical therapy for heart failure for 15 days as defined by: i. No addition or removal of ACE, angiotensin receptor blockers (ARBs), valsartan/sacubitril, beta-blockers, calcium channel blockers (CCBs) or aldosterone antagonists ii. No substantial change in dosage (100% or greater increase or decrease from baseline dose) of ACE, ARBs, beta-blockers, CCBs or aldosterone antagonists 
  • On a diuretic ≥15 days prior to screening visit and a stable diuretic therapy for 7 days

Khan, SadiyaKhan, Sadiya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03030235 STU00204842
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Roshevsky, Daniel Scott 312 695 3264
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Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis: EARLY TAVR trial
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for pa…
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. The Study Device is a bioprosthetic heart valve. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the valve in position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart. The Study Device and its delivery system are not approved for commercial use by the U.S. Food and Drug Administration (FDA) in patients that do not have symptoms of aortic stenosis. To date, more than 12,000 patients have been enrolled in clinical studies with an Edwards THV. The SAPIEN 3 THV that is being investigated for this study has been implanted in over 3,000 patients with symptoms of severe aortic stenosis and has been approved by FDA for those patients. Participation in the study will vary, depending upon the treatment group you are assigned. If you are in the TAVR group, your participation will be for 5 years. If you are in the Clinical Surveillance group, your participation could range from 5 to 10 years. If you are in the registry group, your participation will be for 5 years. We expect up to 166 people will participate in the main study and up to up to 150 in the registry here at Northwestern. A total of 1109 patients will participate in the main study and up to 1000 patients will participate in the registry internationally.
Inclusion Criteria:
Severe aortic stenosis
Patient is asymptomatic
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.

Exclusion Criteria:
Patient is symptomatic.
Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
Aortic valve is a unicuspid, bicuspid, or is non-calcified.
Severe aortic regurgitation (>3+).
Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
Davidson, Charles JDavidson, Charles J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03042104 STU00204517
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Duquette, Audrey 312 926 7078
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AMPLATZER™ Amulet™ Left Atrial Appendage (LAA) Occluder Randomized Controlled Trial
This study is recruiting patients who have a condition called “nonvalvular atrial fibrillation.” Normally, electrical signals from the upper chambers of the heart (atria) travel to the lower chambers of the h…
This study is recruiting patients who have a condition called “nonvalvular atrial fibrillation.” Normally, electrical signals from the upper chambers of the heart (atria) travel to the lower chambers of the heart (ventricles) and cause them to beat in a regular way. During atrial fibrillation, the electrical signals in your heart are not normal and cause the upper chambers of the heart to beat too fast and irregularly. This irregular beating of the heart leads to a slowing of the blood flow in the upper chambers of the heart. In the left upper chamber, there is a small pouch called the left atrial appendage (LAA). Slowing of blood, especially in the LAA, may cause blood clots to form. Blood clots can move from the LAA and travel to the brain, causing a stroke or transient ischemic attack (TIA), also called a mini-stroke. These blood clots can also travel to other parts of the body and block blood vessels. The purpose of the AMPLATZER Amulet Left Atrial Appendage (LAA) Occluder Trial is to find out if the investigational (not yet approved by the FDA for use in the US) Amulet device is safe and effective when compared to an FDA-approved device called the WATCHMAN LAA closure device. We expect up to 25 people here will be in this research study out of 1700 people in the entire study internationally. Participants will be involved in this research study for up to 5 years. After the procedure, participants will be asked to come to clinic for 5 in-person study visits, and will be contacted via telephone by the study team 5 times.
Inclusion Criteria:
18 years of age or older
Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and the patient has not been diagnosed with rheumatic mitral valvular heart disease
At high risk of stroke or systemic embolism defined as CHADS2 score > 2 or a CHA2DS2-VASc score of > 3
Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication
Deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take long term oral anticoagulation.

*Main Exclusion Criteria*
Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation
Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
Indicated for chronic P2Y12 platelet therapy inhibitor
Has undergone atrial septal defect (ASD) repair or has an ASD closure device implanted
Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
Implanted with a mechanical valve prosthesis
Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure
Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization, or intervention or surgery is planned within 60 days after implant procedure
Heart attack within 90 days prior to randomization
Left ventricular ejection Fraction (LVEF) <30%
Symptomatic carotid artery disease Resting heart rate >110 bpm
Knight, Bradley PaulKnight, Bradley Paul
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02879448 STU00204852
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Carswell, Amy 312 926 7554
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REDUCE LAP-HF RANDOMIZED TRIAL II: A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure
The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Invest…
The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Investigational means it has not been approved by the USA Food and Drug Administration (FDA).The device is called the IASD System II, which is an “inter-atrial shunt”. The device is permanently implanted into the heart. It is designed to reduce the pressure in a part of the heart called the left atrium. This is done by creating a small opening between the left atrium and the right atrium of your heart. If it lowers the pressure in your heart at rest or during activity, it may lessen some of the symptoms you have. You have a 50% chance of receiving the device and a 50% chance of being in the control group for 2 years and then you may have the option of receiving the device This study is an FDA approved clinical trial for this device. The FDA will review the safety results and the treatment effect found in this study. If the FDA accepts the research results the FDA can approve the device for sale in the USA. In April 2016, the Study Device received CE Marking, which is an approval that allows it to be sold in the European Union. If you agree to participate in this study, we expect that you will be involved for about five (5) years. Being in this study requires regular doctor visits. There are visits for testing before the procedure. After the procedure, there are visits at 1 month, 3 months, 6 months and 12 months, and then yearly visits until 5 years after the procedure. The study is over when all the subjects have had their last doctor visit. We expect up to 12 people here will be in this research study out of 700 people in the entire study internationally
INCLUSION CRITERIA: 1. Chronic symptomatic heart failure (HF) documented by the following:
a. Symptoms of HF requiring current treatment with diuretics for ≥ 30 days
b. New York Heart Association (NYHA) class II with a prior history of > NYHA class II; NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
c. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV), or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility), within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.
2. Ongoing stable GDMT HF management and management of potential comorbidities according to the 2013 ACCF/AHA Guidelines for the management of Heart Failure, with no significant changes (>100% increase or 50% decrease), excluding diuretic dose changes, for a minimum of 4 weeks prior to screening which is expected to be maintained for 6 months.
3. Age ≥ 40 years old
4. Site determined echocardiographic LV ejection fraction ≥40% within the past 6 months,
without documented ejection fraction <30% in the 5 years prior to study entry.
5. Site determined elevated PCWP with a gradient compared to right atrial pressure (RAP)
documented by:
a. End-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than
RAP by ≥ 5 mm Hg. OR
b. End-expiratory resting PCWP >15mm Hg, and greater than RAP by ≥ 5 mm Hg.
6. Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following:
a. LA diameter > 4 cm; or
b. Diastolic LA volume > 50, LA volume index > 28 ml/m2 or c. Lateral e’ < 10 cm/s; or
d. Septal e’ < 8 cm/s; or
e. Lateral E/e’ > 10 ; or f. Septal E/e’ > 15
7. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the IRB or EC
8. Subject is willing to comply with clinical investigation procedures and agrees to return for all
required follow-up visits, tests, and exams
9. Trans-septal catheterization and femoral vein access to the right atrium is determined to be feasible by site interventional cardiology investigator. EXCLUSION CRITERIA 1. MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months.
2. Cardiac resynchronization therapy initiated within the past 6 months
3. Advanced heart failure defined as one or more of the below:
a. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
b. Cardiac index < 2.0 L/min/m2
c. Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months d. Patient is on the cardiac transplant waiting list
4. Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m
5. The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle and not by shortness of breath and/or fatigue and/or chest pain.
6. Unwilling or unable (per PhysIQ protocol) to wear tele-monitoring patch.
7. Known clinically significant un-revascularized coronary artery disease, defined as: epi-cardial coronary artery stenosis associated with angina or other evidence of coronary ischemia.
8. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
9. Known clinically significant untreated carotid artery stenosis likely to require intervention.
10. Presence of hemodynamically significant valve disease assessed by the site cardiologist and defined as:
a. Mitral valve disease defined as grade ≥ 3+ MR or > mild MS
b. Tricuspid valve regurgitation defined as grade ≥ 2+ TR;
c. Aortic valve disease defined as ≥ 2+ AR or > moderate AS
11. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis)
12. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin (analogue);
or has a documented coagulopathy
13. Atrial fibrillation with resting HR > 100 BPM
14. Resting arterial oxygen saturation < 95% on room air
15. Significant hepatic impairment defined as 3X upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
16. Right ventricular dysfunction, assessed by the site cardiologist and defined as a. More than mild RV dysfunction as estimated by TTE; OR
b. TAPSE < 1.4 cm; OR
c. RV size ≥ LV size as estimated by TTE; OR
d. Ultrasound or clinical evidence of congestive hepatopathy; OR
e. Evidence of RV dysfunction defined by TTE as an RV fractional area change < 35%;
17. Resting RAP > 14 mmHg
18. Evidence of significant pulmonary hypertension defined as PVR > 4 Wood units
19. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as FEV1 <1L.
20. Hemoglobin <10 g/dl
21. Currently participating in an investigational drug or device study that would interfere with the conduct or results of this study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational
22. Life expectancy less than 12 months for known non-cardiovascular reasons
23. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
24. Known or suspected allergy to nickel
25. Fertile women
26. Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation
27. Systolic blood pressure >170 mm Hg.
28. Subjects with existing atrial septal defects. Subjects with a patent foramen ovale (PFO), who meet PCWP criteria despite the PFO, are not excluded.
29. Subjects on significant immunosuppressive treatment or on systemic steroid treatment (>10 mg prednisone/day).
30. Severe obstructive sleep apnea not treated with CPAP or other measures
31. Severe depression and/or anxiety
32. In the opinion of the investigator, the subject is not an appropriate candidate for the study

Ricciardi, MarkRicciardi, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03088033 STU00204899
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Roshevsky, Daniel Scott 312 695 3264
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Assessment of the WATCHMAN(TM) Device in Patients Unsuitable for Oral Anticoagulation
This study will evaluate the safety and effectiveness of the WATCHMAN Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by c…
This study will evaluate the safety and effectiveness of the WATCHMAN Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by chance (“randomized”) to one of two groups: the Device Group or the Control Group. There will be two people assigned to the Device Group for every one person assigned to the Control Group. Participants in the Device Group will be scheduled for WATCHMAN Device implantation. Participants the Control Group will not have the device implanted and will be prescribed single antiplatelet therapy or no therapy for the duration of the trial at the discretion of the study physician. In this study, the WATCHMAN Device itself and the implantation procedure are the same as the FDA approved WATCHMAN. The only difference is that no OAC therapy will be administered after implant. Therefore, the use of the WATCHMAN Device in this study is considered “investigational” because it has not been approved by the FDA for use without short-term OAC therapy. Participants in this study will be in this research study for about 5 years. During this time, participants will be asked to come to clinic for 6-7 study visits, and the study team will contact participants by telephone for 5 phone “visits”. We expect up to 70 people here will be in this research study out of 888 people in the entire study internationally.
Inclusion Criteria:
Documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation. The subject has a calculated CHA2DS2-VASc score of 2 or greater.
Deemed by two study physicians to be unsuitable for oral anticoagulation.
Deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant.
Able and willing to return for required follow-up visits and examinations.

Exclusion Criteria:
The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation).
Planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery).
Prior stroke (of any cause) or TIA within the 30 days prior to randomization.
Prior bleeding event within the 14 days prior to randomization.
History of atrial septal repair or has an ASD/PFO device.
An implanted mechanical valve prosthesis in any position.
The subject suffers from New York Heart Association Class IV Congestive Heart Failure.
The subject has LVEF < 30%.
Knight, Bradley PaulKnight, Bradley Paul
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02928497 STU00205007
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Carswell, Amy 312 926 7554
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INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)
Influenza infection (“the flu”) is known to be associated with a higher risk for heart problems. The purpose of this study is to see if an investigational high-dose influenza (“flu”) vaccine is able to safely reduce heart or lung-related problems compared to the standard-dose flu vaccine. Both the high dose and standard dose flu vaccines called Fluzone® are being provided for use in the study by Sanofi Pasteur, which manufactures the vaccines. The standard dose vaccine is approved by the Food and Drug Administration (FDA) for protecting against influenza disease caused by influenza A and influenza B viruses.  The high dose vaccine is approved by the FDA for the same reason, but only for adults who are at least65 years old. Thus its use with adults younger than 65 in this study is investigational.
This study is recruiting patients who have had a heart attack or have heart failure.
Mutharasan, RMutharasan, R
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02787044 STU00205380
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Reinkensmeyer, Larissa 312 695 2928
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A multi-center, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular disease
The purpose of this study is to find out whether a drug called “macitentan” works and is…
The purpose of this study is to find out whether a drug called “macitentan” works and is safe in patients with Heart Failure with Preserved Ejection Fraction and Pulmonary Vascular Disease. There are several drugs available to manage heart failure symptoms, but to date, no treatments have been approved specifically for left heart failure with preserved ejection fraction and pulmonary vascular disease. Macitentan may reduce unwanted effects of a chemical substance in the body called endothelin, which has been detected in increased amounts in patients with heart failure. Endothelin causes blood vessels to narrow and results in overgrowth of the muscle in the walls of the lung blood vessels and also of the heart. By blocking the action of endothelin, macitentan lowers the blood pressure in the pulmonary arteries, may slow down overgrowth of the heart muscle and may therefore improve your condition. Macitentan has been tested and approved in the U.S. for other diseases, but is considered experimental for the use in this study. We expect participants will be in this research study for 70 weeks, and will need to come to clinic for study visits 13 times. We expect up to 5 people here will be in this research study out of 300 people in the entire study internationally.
Signs or symptoms of Heart Failure (HF) requiring treatment with at least one oral diuretic (any type). Left ventricular ejection fraction (LVEF) ≥ 40% . Structural heart disease consistent with heart failure with preserved ejection fraction (HFpEF). HF hospitalization within 12 months prior to Screening and/or cardiac catheterization performed within 6 months prior to Screening.  Pulmonary vascular disease or right ventricular dysfunctionExclusion Criteria: Any prior measurement of LVEF < 40%. Cardiovascular co-morbidities (e.g., significant unrepaired structural valvular heart disease; acute coronary syndrome, coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within 3 months of Screening; uncontrolled heart rate from atrial fibrillation or atrial flutter, history of serious life-threatening or hemodynamically significant arrhythmia) Hemoglobin < 100g/L (< 10 g/dl) Significant lung disease (e.g., severe COPD, moderate or severe restrictive lung disease, diffuse interstitial fibrosis or alveolitis, pulmonary thromboembolism) Severe renal dysfunction with an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min per 1.73 m2 Severe hepatic impairment, e.g., Child Pugh Class C.
Freed, BenjaminFreed, Benjamin
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03153111 STU00205418
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Sanchez, Cynthia 312 695 5097
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Real Life Multimarker Monitoring in Patients with Heart Failure (REALIsM-HF)

The study aims to explore two marketed devices, monitoring physical activity under real-life conditions in patients with HFpEF and HFrEF. 

Furthermore, it aims to address the challenges and feasibility of imple…

The study aims to explore two marketed devices, monitoring physical activity under real-life conditions in patients with HFpEF and HFrEF. 

Furthermore, it aims to address the challenges and feasibility of implementing device based measurements under real-life conditions.

Female and male subjects with a diagnosis of acute decompensated heart failure with preserved ejection fraction (HFpEF; EF ≥ 45%) or

acute decompensated heart failure with reduced ejection fraction (HFrEF; EF ≤ 35%) will be enrolled.

Shah, Sanjiv JShah, Sanjiv J
  • Map it 201 E. Huron St.
    Chicago, IL
STU00206315
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Reinkensmeyer, Larissa 312 695 2928
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Microtubule Polymerization of Modulators for Treating LMNA-Related Dilated Cardiomyopathy
This study is enrolling patients diagnosed with LMNA-related dilated cardiomyopathy (DCM), who have an irregular heart rhythm (arrhythmia) or their heart is not working properly (myocardial dysfunction). For thi…
This study is enrolling patients diagnosed with LMNA-related dilated cardiomyopathy (DCM), who have an irregular heart rhythm (arrhythmia) or their heart is not working properly (myocardial dysfunction). For this study, we are evaluating use of a medication, colchicine, to see if it can help improve heart function and reduce irregular heart rhythms in patients with LMNA related DCM
1. Confirmed diagnoses of LMNA cardiomyopathy (confirmed with genetic testing). 2. Evidence of myocardial dysfunction OR cardiac arrhythmia
Wilcox, Jane ElizabethWilcox, Jane Elizabeth
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
STU00206184
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Roshevsky, Daniel Scott 312 695 3264
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Dilated Cardiomyopathy (DCM) Research Project
Dilated cardiomyopathy (DCM) is a condition in which the heart becomes enlarged and the heart muscle weakened, causing the heart to pump blood less efficiently. DCM is commonly caused by heart muscle damage (“a heart attack”) from coronary artery di…
Dilated cardiomyopathy (DCM) is a condition in which the heart becomes enlarged and the heart muscle weakened, causing the heart to pump blood less efficiently. DCM is commonly caused by heart muscle damage (“a heart attack”) from coronary artery disease. Other causes include exposure to some drugs, such as cancer chemotherapy. When the cause is unknown, it is called idiopathic DCM. Among individuals with idiopathic DCM, having relatives undergo a cardiac check-up (echocardiogram, ECG) will reveal familial DCM in up to one-third of cases. A high level of suspicion of familial DCM is also raised when family members have had heart failure, a heart transplant, sudden death (without a history of coronary artery disease), or arrhythmias, which sometimes require a pacemaker or defibrillator. WHAT DOES THIS STUDY INVOLVE? IF YOU HAVE IDIOPATHIC DCM: Participation involves inviting all your first-degree relatives (children, parents, siblings) with or without heart disease. If you have other more distant relatives with DCM, they are also welcome to participate. To help with this process, we provide a letter that you can share with your relatives, and a family history questionnaire for you to complete. You may also receive a communication tool to help you invite your family members to the study. Your participation also involves providing cardiovascular information and medical records, completing annual surveys, and a blood draw. FOR FAMILY MEMBERS: Participation of family members involves collecting cardiac information and a blood draw. To better understand the genetic cause of DCM, it is helpful to compare results from family members with and without the condition. Because DCM can be present but silent for years, it is difficult to know with certainty if a family member does or does not have DCM unless a cardiac check-up is performed. Medical guidelines recommend this for 1st degree family members of individuals with DCM. Therefore, we also ask family members who enroll to obtain cardiac screening with both an echocardiogram and an electrocardiogram (ECG) if they have not done so recently.
Inclusion Criteria:

Meeting criteria for dilated cardiomyopathy (DCM) :
Left ventricular ejection fraction <50%
Left ventricular enlargement (A left ventricular end-diastolic dimension > 95%tile population standard based on gender and height).
Detectable causes of cardiomyopathy, except genetic, excluded beyond a reasonable doubt at the time of DCM diagnosis (that is, meeting clinical criteria for idiopathic DCM)
Any age (including children)
Non-Hispanic and Hispanic ethnicity
All races (PI pre-approval required for recruitment beyond pre-specified recruitment targets).
Ability to give informed consent
Ability to communicate in English (except Spanish language at sites approved to recruit individuals of Hispanic ethnicity)
Willingness to participate in a family-based study (patient willing to work with a clinical site and/or OSU to facilitate the recruitment and enrollment of family members to the study).

Exclusion Criteria:

Coronary artery disease (CAD) causing ischemic cardiomyopathy (> 50% narrowing, any major epicardial coronary artery)
Primary valvular disease
Adriamycin or other cardiotoxic drug exposure
Other forms of cardiomyopathy: Hypertrophic, Restrictive, or Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy
Congenital heart disease
Other detectable causes of dilated cardiomyopathy, including sarcoid and hemochromatosis.
Other active multi-system disease that may cause DCM (e.g., active connective tissue disease).
Severe and untreated or untreatable hypertension (systolic blood pressures routinely greater than 180 mm Hg and/or diastolic blood pressures greater than 120 mm Hg, and if resistant to multidrug treatment).
However, conventional risk factors for DCM, including obesity, routinely treated hypertension, alcohol use, pregnancy or the peri-partum period, or left ventricular noncompaction, will NOT be considered exclusion criteria.
Wilcox, Jane ElizabethWilcox, Jane Elizabeth
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03037632 STU00205850
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Whisler, Cailin 312 926 3356
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Edwards Cardioband™ Tricuspid Valve Reconstruction System Early Feasibility Study
This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve recons…
This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve reconstruction system. This is an early feasibility clinical research study that will evaluate the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System, (the “Study Device” ). The Study Device includes an adjustable implant that is delivered and anchored to the tricuspid valve by a transfemoral delivery system, meaning it is inserted in a minimally invasive procedure through a puncture into a vein in the leg. The Cardioband Implant will be positioned around the tricuspid valve and will be adjusted to reduce the size of the valve, thus improving the tricuspid regurgitation. Up to 15 patients will be enrolled in this study at up to 15 sites. All enrolled study patients will be assessed at the following intervals: screening/baseline, procedure, discharge, 1 month, 6 months, 1 year and annually for 5 years post implant procedure.
Davidson, Charles JDavidson, Charles J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03382457 STU00207338
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Christensen, Lyndsay 312 694 0661
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17-518: The MitraClip® EXPAND Study A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip® Devices

This study is being conducted to collect information on the use and outcomes of the MitraClip System in everyday medical treatment.

Participating in this study will not impact the treatment that you receive for your MR. Information about your health and the results of your treatment with the MitraClip system will be collected and documented during the implantation procedure, while you are in the hospital,and from your regularly scheduled clinic visits at 30 days and 1 year after the implant.  You will not need to come in for extra visits or have additional procedures done for the study. Study staff will call you 6 months after the implant to ask how you are feeling and if you have had any problems or side effects.

This study is recruiting patients who will be receiving a MitraClip System device as part of their standard care for mitral regurgitation (MR).
Ricciardi, MarkRicciardi, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
STU00207858
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Brady, Caitlin +1 312 926 5968
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