Coronavirus information for Feinberg.

Skip to main content

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
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 ChrisMalaisrie, S Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03003299 STU00204739
More Info
Copy
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
More Info
Copy
AF STOP: AF Substrate as an Outcome and Predictor of successful AF ablation
To improve the understanding of factors associated with the atrial myopathy in people with AF or people at risk for developing AF
Primary Inclusion Criteria:
  • Patients ≥ 18 years old
  • Patients with paroxysmal or early persistent AF undergoing routine pulmonary vein isolation (PVI)
  • Subjects who are scheduled to undergo clinically ordered cardiac MRI for planning of AF ablation

Primary Exclusion Criteria:

  • Longstanding persistent AF (continuous AF > 1 year) or AF from a reversible cause
  • Previous catheter or surgical ablation for AF
  • Contraindication to MRI
  • Advanced chronic renal insufficiency (GFR < 30 mL/min/1.73 m2), anemia (hemoglobin < 10 g/dL) or thrombocytopenia (platelet count < 100K/UL)
  • History of pulmonary emboli, CVA or TIA (within the past 6 months), atrial clot/thrombus on imaging, or blood clotting/bleeding abnormalities
Passman, Rod SPassman, Rod S
  • Map it 201 E. Huron St.
    Chicago, IL
STU00207885
More Info
Copy
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with mitral regurgitation
The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

Primary Inclusion Criteria:

  • Patient is determined to be at prohibitive risk for mitral valve surgery by a heart team
  • Mitral regurgitation (3+ to 4+) by echo (TTE or TEE) as measured by the core lab
  • Left ventricular ejection fraction (LVEF) ≥ 20%
  • Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03706833 STU00208635
    More Info
    Copy
    Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial (TAVR UNLOAD)

    The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to m…

    The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to meet the body's needs) who have moderate aortic stenosis (AS - narrowing of the aortic valve resulting in obstructed blood flow). This clinical trial is comparing the safety and effectiveness of TAVR (Transcatheter Aortic Valve Replacement) with the Edwards SAPIEN 3 Transcatheter Heart Valve (the Study Valve) and OHFT (optimal heart failure therapy) versus OHFT alone in HF patients with moderate AS. The study valve has not been approved by the U.S. Food and Drug Administration (FDA) for use in this patient population, and therefore it's use in this study is considered investigational.
    This study is looking for patients with Heart Failure and moderate Aortic Stenosis. Aortic Stenosis is a narrowing of the aortic valve opening,which blocks blood flow from the heart and causes symptoms such as chest pain,fainting and shortness of breath.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02661451 STU00208415
    More Info
    Copy
    SUPERIOR VENA CAVAL OCCLUSION IN SUBJECTS WITH ACUTE DECOMPENSATED HEART FAILURE- AN EARLY FEASIBILITY STUDY
    This study is enrolling patients who have Acute Decompensated Heart Failure (ADHF) and are having or recently had a cardiac catheterization procedure as part of their clinical care (not part o…
    This study is enrolling patients who have Acute Decompensated Heart Failure (ADHF) and are having or recently had a cardiac catheterization procedure as part of their clinical care (not part of the research).The reason we are doing this research study is to look at the preCARDIA device (the “study device”) to see if it can help treat Advanced Heart Failure. This type of research study is called an “early feasibility study”. Early feasibility studies typically evaluate innovative devices or innovative uses of approved devices. These studies enroll a small number of participants and provide initial information on the basic safety and performance of the study device when used to treat a specific patient type. The study device is investigational and not approved by the US Food and Drug Administration (FDA) for your medical condition. In patients with advanced heart failure, specifically severely congested patients with Acute Decompensated Heart Failure (ADHF), poor heart function leads to an excess of fluid in the right side of the heart (“fluid overload”) and symptoms such as shortness of breath. Drugs such as diuretics are designed to improve these symptoms and heart function by reducing fluid overload. However, diuretics take time to work and may be ineffective in patients with advanced heart failure, a phenomenon known as diuretic resistance. For this reason, a device-based approach designed to limit fluid overload is being studied to see if it could possibly improve symptoms and heart function in congested patients with advanced heart failure. The study device will temporarily block (“occlude”) one of the veins that return blood to the heart in order to potentially reduce fluid buildup and potentially improve the heart’s pumping function temporarily.
    Benzuly, Keith HBenzuly, Keith H
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03836079 STU00210029
    More Info
    Copy
    The “RADIANCE II” Pivotal Study A Study of the ReCor Medical Paradise System in Stage II Hypertension
    This study is enrolling patients who have high blood pressure ("hypertension") and are taking two medications or fewer for it. It is believed that in some patients with high blood pressure, the n…
    This study is enrolling patients who have high blood pressure ("hypertension") and are taking two medications or fewer for it. It is believed that in some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys (renal arteries) are too active and that this may be causing high blood pressure. Renal denervation is a procedure where a catheter is placed inside these blood vessels and creates heat to disable the nerves and potentially lower blood pressure. The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in patients who are known to have hypertension.
    Benzuly, Keith HBenzuly, Keith H
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03614260 STU00209790
    More Info
    Hypertension HTN
    Copy
    Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation
    This study is enrolling patients with severe Tricuspid Regurgitation (TR), a condition in the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction. The standard medical treatments generally available to patients with tricuspid regurgitation who do not undergo surgery, may temporarily alleviate some symptoms, but will not permanently alleviate or cure tricuspid regurgitation.  The goal of this trial is to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System (hereinafter referred to as the PASCAL System) with optimal medical therapy (OMT) compared to OMT alone in the treatment of participants with symptomatic severe tricuspid regurgitation who may not be ideal candidates for tricuspid valve surgery (performed via open-heart surgery) and may be eligible for transcatheter tricuspid valve repair (minimally invasive procedure that repairs the valve). Optimal Medical Therapy (OMT) refers to standard of care treatment using recommended medications
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04097145 STU00211052
    More Info
    Copy
    Right Ventricular Ischemia and Fibrosis in Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
    This study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angiopl…
    This study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angioplasty (BPA) procedure for treatment. CTEPH is high blood pressure in the arteries in the pulmonary system (lungs) caused by clots. Over time the clots typically leave scar tissue (fibrosis) in the arteries and lead to poor blood supply to the heart. In patients with CTEPH symptoms of heart failure commonly result from dysfunction (not working correctly) in the right ventricle (RV), or the chamber of the heart that pumps blood to the lungs. However, little is currently known about why or how that chamber of the heart becomes dysfunctional in patients with this condition. In another chamber of the heart, the left ventricle, it is known that elevated blood pressure in that chamber causes the development of diffuse fibrosis, or scarring between the muscle fibers, and a similar process may take place in the right ventricle of patients with CTEPH.

    For this study a cardiac magnetic resonance imaging (MRI) stress test (also known as stress CMR) will be done to look at the RV in patients with CTEPH before and 6 months after treatment. A stress CMR is a specialized scan of the heart that examines fibrosis (scarring) and blood flow (perfusion) both at rest and under stress. A gadolinium contrast agent (MRI dye) is given to highlight the heart muscle in areas receiving a good blood supply. Areas receiving less blood do not highlight as well as the good areas, which can be an indicator of ischemic heart disease (undersupply of blood and oxygen to the heart).

    Freed, Benjamin HowardFreed, Benjamin Howard
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    STU00210998
    More Info
    Copy
    pHysiological signals, Activity and Posture for surface mounted Insertable Cardiac Monitor in Heart Failure (HAPI-HF) Study
    This study is enrolling patients to use a wearable insertable cardiac monitor to better understand the various sounds that the heart makes during cardiac tests. You are being as…
    This study is enrolling patients to use a wearable insertable cardiac monitor to better understand the various sounds that the heart makes during cardiac tests. You are being asked to participate in this study because Boston Scientific Corporation (BSC) is making a device called the insertable cardiac monitor (ICM) that measures certain heart functions. The device also works when it is placed on top of the chest. BSC made a more comfortable, wearable version of the device to use in this study. The wearable device is called the wearable cardiac monitor (WCM). As part of the study, the WCM will collect data during tests while taped to the skin. The tests include leg raise exercises, lying down, sitting and/or standing, and an optional submaximal exercise test for participants the study doctor determines appropriate. There may also be an echocardiogram during these tests. An echocardiogram takes pictures of the heart using sounds waves created by the heart. The purpose of this study is to collect data during a series of tests to see if the WCM can detect signals related to heart failure. This data will be compared to the data obtained by the echocardiogram.
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04112576 STU00210829
    More Info
    Copy
    Percutaneous MitraClipTM Device or Surgical Mitral Valve REpair in PAtients with PrImaRy Mitral Regurgitation who are Candidates for Surgery (REPAIR MR)
    The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart su…
    The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less invasive procedure to repair the mitral valve.

    Subjects are asked to participate in this Study because they have moderate-to-severe or severe MR and it has been determined to have symptoms due to heart failure despite being treated with currently available therapies. MR occurs when the leaflets of the mitral valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart needs to pump more blood with each beat to push the same amount of blood forward.

    The Study will enroll approximately 500 subjects at up to 60 sites in Europe, United States, and Canada. The Study consists of two arms: Device Arm and Control Arm.

    • Subject has severe (Grade III or greater per the ASE criteria, which includes severitygrades of 3+ and 4+) primary MR (mixed etiology is acceptable provided theprincipal mechanism of action is a degenerative mitral valve) as assessed bythe ECL.
    • Subject is at least 75 years of age

    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04198870 STU00211557
    More Info
    Copy
    Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal (TRILUMINATE Pivotal)
    The purpose of this research study is to compare the safety and effectiveness of an investigational tricuspid valve repair system, called TriClip TM Device, whic…
    The purpose of this research study is to compare the safety and effectiveness of an investigational tricuspid valve repair system, called TriClip TM Device, which is inserted into the heart, along with using optimal drug therapy for your heart condition versus optimal drug therapy alone. The Study will enroll approximately 700 subjects at up to 80sites in Europe, United States and Canada. Up to 50 participants will be enrolled at Northwestern. The Study is made up of three different groups: Randomized(up to 450), Roll-In (up to 150, and Single-Arm Registry (up to 100).
    • Age ≥18 years at time of consent.
    • Subject has been diagnosed with moderate or greater tricuspid regurgitation determined to have symptoms due to heart failure despite being treated with currently available therapies
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03904147 STU00210487
    More Info
    Copy
    A Multi-Center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK­3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
    This study is enrolling pa…
    This study is enrolling patients who have obstructive hypertrophic cardiomyopathy (oHCM). Obstructive HCM is a condition in which the heart muscle in the left ventricle (LV) becomes abnormally thickened, which can block blood flow out of the heart to the body. This obstruction causes the LV heart muscle to work harder to pump blood to the body and can cause symptoms of chest pain, dizziness, shortness of breath and fainting. This is the first time the investigational drug called CK-3773274 is being studied in participants who have oHCM, but it has already been studied in healthy volunteers. The purpose of this study is to learn how well CK-3773274 is tolerated at different, increasing dose levels in patients with oHCM and if it causes any side effects. The study will also measure the amount of CK-3773274 in your blood at various times, and the effect the study drug may have on your oHCM. CK-3773274 is an investigational (experimental) study drug. This means that CK-3773274 has not been approved by the U.S. Food and Drug Administration (FDA) for use outside of a research study.
    Choudhury, LubnaChoudhury, Lubna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04219826 STU00211491
    More Info
    Copy
    A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)
    This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which i…
    This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). This change can either be sporadic which is known as wild-type (wtATTR-CM) or due to a mutation of the TTR gene which is hereditary (hATTR-CM). In both cases, these changes can cause the TTR to clump and build up in certain parts of the body such as the nervous system, stomach, intestines, and heart. This build up is called an amyloid deposit. Amyloid deposits can sometimes cause heart disease or neuropathy (nerve damage). When amyloid is deposited into the heart, it can result in a condition referred to as cardiomyopathy. ION-682884 is an investigational drug. “Investigational” means that ION-682884 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. ION-682884 reduces the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in the blood may reduce the amount of amyloid deposits in the body and may keep cardiomyopathy from getting worse over time. However, it is not known if ION-682884 will help cardiomyopathy. The purpose of this study is to evaluate the safety of ION-682884 and determine if it can help people with this type of cardiomyopathy.
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04136171 STU00211443
    More Info
    Copy
    Targeting Inflammation and Alloimmunity in Heart Transplant Recipients with Tocilizumab

    This study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejectio…

    This study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejection of the transplanted heart. In addition, the immune system (your body’s defenses to protect against disease) will be activated by the presence of the new heart. Investigators believe that a drug called tocilizumab (ACTEMRA®) might reduce or prevent inflammation and reduce the immune system’s response to the new heart, and that this would improve the long-term health of your new heart. The purpose of this research study is to see if a study drug called Actemra® (tocilizumab) will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Tocilizumab is a prescription medicine approved by the US Food and Drug Administration (FDA) to treat rheumatoid arthritis (RA) and other inflammatory diseases. Tocilizumab has not been used before to treat people who receive a heart transplant. We don’t know if it will be good for people who have a heart transplant. Tocilizumab is not approved by the FDA to treat heart transplant patients, and therefore using it in this study is considered investigational.

    Ghafourian, KambizGhafourian, Kambiz
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03644667 STU00212222
    More Info
    Copy
    Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device
    This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the…
    This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. The goal of this trial is to evaluate the safety and effectiveness of the Study Device with Optimal Medical Therapy (OMT) compared to OMT alone in the study of subjects with severe or greater tricuspid regurgitation.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04482062 STU00213338
    More Info
    Copy
    AN EXPLORATORY, OPEN-LABEL, PROOF-OF-CONCEPT, PHASE 2A STUDY OF MAVACAMTEN (MYK-461) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF) AND CHRONIC ELEVATION OF CARDIAC TROPONIN I AND/OR NT-PROBNP
    This study is recruiting patients who have been diagnosed with Heart Failure wi…
    This study is recruiting patients who have been diagnosed with Heart Failure with Preserved Ejection Fraction. The study will test whether a drug called mavacamten can lower blood levels of cardiac troponin (a marker of heart muscle injury) and/or NT-proBNP (a marker of heart wall stress). These “biomarkers” are increased in the blood of some people with HFpEF. Additionally, the main research study will provide preliminary information regarding tolerability and safety of mavacamten treatment in HFpEF. Mavacamten is an investigational drug. This means that it has not been approved by the Food and Drug Administration (FDA) or any regulatory agency for routine clinical use, including the treatment of HFpEF.
    Patel, Ravi BPatel, Ravi B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04766892 STU00213899
    More Info
    Copy
    An Open-Label, Exploratory Study of the Safety and Preliminary Efficacy of Danicamtiv in Stable Ambulatory Patients with Primary Dilated Cardiomyopathy due to either MYH7 or TTN Variants
    This study is recruiting patients aged 18-80 years and who have been diagnosed with dilated cardiomyopathy due to …
    This study is recruiting patients aged 18-80 years and who have been diagnosed with dilated cardiomyopathy due to a mutation in either MYH7 or TTN, both of which are genes involved in the function of heart muscle. The purpose of Part A of this study is to evaluate the safety, tolerability, and cardiac pharmacodynamics (the effect of the drug on your heart) of the study drug, danicamtiv, when administered by mouth twice a day for approximately one to two weeks. Once you complete Part A of the study, you will have the option to continue onto Part B of the study and receive study drug for approximately another 96 weeks.

    Danicamtiv is being developed to improve the pumping function of the heart muscle for subjects with large hearts that do not pump blood as well as normal hearts, known as dilated cardiomyopathy, and heart failure with reduced ejection fraction (the heart cannot pump enough blood to meet the body's needs).

    Wilcox, Jane EWilcox, Jane E
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04572893 STU00214902
    More Info
    Copy
    A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients with Non-obstructive Hypertrophic Cardiomyopathy
    This study is recruiting patients with a diagnosis of hypertrophic cardiomyopathy (HCM) who are able to perform a tread…
    This study is recruiting patients with a diagnosis of hypertrophic cardiomyopathy (HCM) who are able to perform a treadmill cardiopulmonary exercise test.  The safety and tolerability of investigative study drug IMB-1018972 is being studied in patients with non-obstructive hypertrophic cardiomyopathy. This study will also exmaine the effect of IMB-1018972 on exercise capacity and how the heart uses energy.
    Choudhury, LubnaChoudhury, Lubna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04826185 STU00215049
    More Info
    Copy
    Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)
    The purpose of this study is to assess the safety and effectiveness of the AccuCinch Ventricular Restoration System and compar…
    The purpose of this study is to assess the safety and effectiveness of the AccuCinch Ventricular Restoration System and compare it to standardized heart failure medications.  The AccuCinch Ventricular Restoration System is an investigational (experimental) device intended to treat patients who are experiencing symptoms of heart failure due to a dilated (enlarged) left ventricle (heart chamber which pumps blood).   
    Flaherty, James DFlaherty, James D
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04331769 STU00214441
    More Info
    Copy