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Clinical Trials

As part of an academic medical center, the Department of Medicine at Northwestern University Feinberg School of Medicine aims to improve the human health through scientific research.

About Clinical Trials

Clinical trials test or study drugs, surgical procedures, medical devices or interventions with human subjects. They look to determine their safety and effectiveness in relation to treating specific diseases. Clinical trials are part of clinical research and are at the heart of all medical advances.

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Department of Medicine Clinical Trials

The following searchable list includes all Division of Division of Cardiology, Department of Medicine clinical trials currently looking for participants.

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Trials

Quantitative Detection of Coronary Microvascular Dysfunction in Long COVID Patients Using a Comprehensive, Rapid, Free-Breathing Cardiovascular MRI

This research study involves the use of Magnetic Resonance Imaging (MRI) to study the effectsof COVID-19 on the heart. Since COVID-19 is a new disease, we do not yet understand thedifferent ways that it may effect the body. There is some evidence that individuals with COVID-19 are …

This research study involves the use of Magnetic Resonance Imaging (MRI) to study the effects

of COVID-19 on the heart. Since COVID-19 is a new disease, we do not yet understand the

different ways that it may effect the body. There is some evidence that individuals with COVID-

19 are at higher risk for heart complications. The purpose of this study is to use recently

developed MRI techniques to compare heart health of individuals with COVID-19 to people who

were asymptomatic or are healthy. The new MRI techniques used in this experiment may also allow researchers and health care providers to take clearer pictures of the heart in other

individuals.

Eligibility Criteria
  • No kidney disease (eGFR is greater than 45)
  • Does not have severe claustrophobia
Principal InvestigatorKim, DanielKim, Daniel
Location(s)
  • Map it 201 E. Huron St.
    Chicago, IL
IRB number STU00205520
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CLASP IID/IIF

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 …
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.
Eligibility Criteria

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%
  • Principal InvestigatorDavidson, Charles JDavidson, Charles J
    Location(s)
    • Map it 201 E. Huron St.
      Chicago, IL
    ClinicalTrials.gov IdentifierNCT03706833IRB number STU00208635
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    RV Ischemia & Fibrosis in 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 angioplasty (BPA) procedure for treatment. CTEPH is high blood pressure in the arteries in the pulmonary system (lungs) caused by clots. Over time …
    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).

    Principal InvestigatorFreed, Benjamin HowardFreed, Benjamin Howard
    Location(s)
    • Map it 201 E. Huron St. Suite 12 160​
      Chicago, IL
    IRB number STU00210998
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    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 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 …
    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.

    Eligibility Criteria

    • 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

    Principal InvestigatorDavidson, Charles JDavidson, Charles J
    Location(s)
    • Map it 201 E. Huron St.
      Chicago, IL
    ClinicalTrials.gov IdentifierNCT04198870IRB number STU00211557
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    Precision MRI of Left Atrial Fibrosis for Patients with Atrial Fibrillation

    To develop new MRI approaches that can better quantify the severity of left atrial fibrosis, for the purposes of predicting whether patients will revert to atrial fibrillation (AF) following an initial successful procedure…

    To develop new MRI approaches that can better quantify the severity of left atrial fibrosis, for the purposes of predicting whether patients will revert to atrial fibrillation (AF) following an initial successful procedure

    Eligibility Criteria

    Primary Inclusion Criteria:

    • Patients ≥ 18 years old
    • Patients with paroxysmal or persistent AF undergoing routine pulmonary vein isolation (PVI)
    • Patients undergoing a cardiac MRI prior to AF ablation

    Primary Exclusion Criteria:

    • Contraindication to MRI
    • Abnormal renal function (eGFR < 60 mL/min/1.73 m2)

    Principal InvestigatorKim, DanielKim, Daniel
    Location(s)
    • Map it 710 N. Fairbanks Ct. Olson Pavilion
      Chicago, IL
    • Map it 710 N. Fairbanks Court
      Chicago, IL
    IRB number STU00213834
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    CY6022

    A FOLLOW-UP, OPEN-LABEL, RESEARCH EVALUATION OF SUSTAINED TREATMENT WITH AFICAMTEN (CK3773274) IN HYPERTROPHIC CARDIOMYOPATHY (HCM)

    Eligibility Criteria
    • Completion of a Cytokinetics study investigating CK-3773274. If unable to complete due to circumstances not related to compliance or safety, Medical Monitor may review and determine eligibility.
    • LVEF ≥ 55%
    Principal InvestigatorChoudhury, LubnaChoudhury, Lubna
    Location(s)
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    ClinicalTrials.gov IdentifierNCT04848506IRB number STU00214844
    More Info
    Keywords HCM
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    REBIRTH

    The study will enroll women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized trial of bromocriptine therapy to evaluate its impact on myocardial recovery.

    Eligibility Criteria
  • Presentation with a new diagnosis of peripartum cardiomyopathy
  • Post-delivery and within the first 5 months post-partum.
  • Clinical assessment of an LVEF < 0.35 within 2 weeks of consent
  • Principal InvestigatorFreaney, Priya M.Freaney, Priya M.
    Location(s)
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    ClinicalTrials.gov IdentifierNCT05180773IRB number STU00217144
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    ALLIANCE AVIV

    Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

    Eligibility Criteria
    • Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
    • Bioprosthetic valve size suitable for SAPIEN X4 THV based on computed tomography angiography (CTA) analysis
    • NYHA functional class ≥ II
    Principal InvestigatorMalaisrie, S. ChrisMalaisrie, S. Chris
    Location(s)
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    ClinicalTrials.gov IdentifierNCT05172960IRB number STU00217246
    More Info
    Keywords Sapien Valve
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    RESPONDER-HF

    Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure

    Eligibility Criteria
    • Chronic symptomatic heart failure (HF)
    • Ongoing stable GDMT HF management and management of comorbidities according to the 2022 ACC/AHA Guidelines for the Management of Heart Failure.
    Principal InvestigatorFlaherty, James DFlaherty, James D
    Location(s)
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    ClinicalTrials.gov IdentifierNCT05425459IRB number STU00217812
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    REACT-AF

    Rhythm Evaluation for AntiCoagulaTion with Continuous Monitoring of Atrial Fibrillation

    Eligibility Criteria
    • Documented history of symptomatic or asymptomatic paroxysmal or persistent AF
    • CHA2DS2-VASC score of 1-4 without prior stroke or TIA
    • Participant is on a DOAC at time of screening
    Principal InvestigatorKnight, Bradley PaulKnight, Bradley Paul
    Location(s)
    • Map it 1000 N. Westmoreland Road Main Entrance
      Lake Forest, IL
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    ClinicalTrials.gov IdentifierNCT05836987IRB number STU00219005
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    AVENTUS

    AVENTUS: Assessing the Safety and Efficacy of the treatment for Acute Pulmonary Embolism using the Inquis Medical Aventus Thrombectomy System™

    Eligibility Criteria
    • PE symptom(s) duration ≤ 14 days from index procedure
    • PE diagnosis ≤ 48 hours prior to index procedure
    • CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery based on Investigator determination)
    • CTA evidence of dilated RV with an RV/LV ratio of ≥ 0.9 at baseline based on Investigator determination
    • Systolic blood pressure ≥ 90 mmHg without need for vasopressors (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with intravenous fluids prior to index procedure)
    • Stable heart rate < 130 BPM prior to index procedure
    Principal InvestigatorSchimmel, Daniel RichardSchimmel, Daniel Richard
    Location(s)
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    ClinicalTrials.gov IdentifierNCT05907564IRB number STU00219642
    More Info
    Keywords PE Thrombectomy
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    Pulmonary Artery DenerVation Clinical Study using the Gradient Denervation System in Heart Failure Patients with Pulmonary Hypertension Group 2 (PreVail-PH2 Study)

    Prospective, single arm, multi-center, early feasibility study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension…

    Prospective, single arm, multi-center, early feasibility study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

    Eligibility Criteria

    Ambulatory with an age of 22-85 years at time of enrollment

    Heart Failure with EF ≥ 40% (by TTE within last 3 months)

    NYHA Class II or III

    Principal InvestigatorSchimmel, Daniel RichardSchimmel, Daniel Richard
    Location(s)
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    ClinicalTrials.gov IdentifierNCT06052072IRB number STU00220161
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    The ANTICIPATE Study

    Assessment of Parameters Predicting Heart Failure Events in Patients with Heart Failure

    Eligibility Criteria
    • Patient with HF who signed the informed consent forms accepting his/her data collection and tele transmission
    • Patient Presenting “acute heart failure event"
    • Patient with blood test data ([B-type natriuretic peptide (BNP) or N-Terminal pro B type natriuretic peptide (NT-proBNP) at the acute HF event
    • Patient with HF class III and IV according to the New York Heart Association functional classification
    Principal InvestigatorTibrewala, AnjanTibrewala, Anjan
    Location(s)
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    IRB number STU00220979
    More Info
    Keywords heart failure
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    MAGNITUDE

    A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the

    Efficacy and Safety of NTLA-2001 in Participants with Transthyretin Amyloidosis with Cardiomyopathy

    Eligibility Criteria

    Diagnosis of ATTR-CM

    Medical history of HF

    Treatment for HF/ATTR-CM is optimized and symptoms are clinically stable

    Principal InvestigatorShah, Sanjiv JShah, Sanjiv J
    Location(s)
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    ClinicalTrials.gov IdentifierNCT06128629IRB number STU00220347
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    SONATA-HCM

    A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of SOtaglifloziN in symptomATic obstructive And non-obstructive Hypertrophic CardioMyopathy

    Eligibility Criteria
    • NYHA functional class II or III
    • A diagnosis of HCM
    • For oHCM, LVOT peak gradient ≥ 30 mm Hg at rest OR during a Valsalva maneuver at Screening visit
    • For nHCM, LVOT peak gradient < 30 mm Hg at rest AND during a Valsalva maneuver at Screening visit
    • Screening LVEF ≥ 50%. For patients on a cardiac myosin inhibitor, the Screening LVEF must be ≥ 55%
    Principal InvestigatorChoudhury, LubnaChoudhury, Lubna
    Location(s)
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    ClinicalTrials.gov IdentifierNCT06481891IRB number STU00222081
    More Info
    Keywords HCM
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    RECHARGE Trial: REvascularization CHoices Among under-Represented Groups Evaluation

    This study aims to compare the effect of PCI vs CABG on survival and improvement in QOL in patients who are either Black or Hispanic, or Women

    Eligibility Criteria
    • Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to local Heart Team assessment
    Principal InvestigatorBenzuly, Keith HBenzuly, Keith H
    Location(s)
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    ClinicalTrials.gov IdentifierNCT06399705IRB number STU00222675
    More Info
    Keywords CABG PCI CAD
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    SEISMIC-HF II

    This is a multi-site observational study to collect data for performance evaluation of Cardiosense investigational software

    Eligibility Criteria
    • Patient has a history of heart failure
    • Patient has a left ventricular ejection fraction measured within 6 months of study enrollment recorded in the medical record
    • Patient is scheduled to undergo a right heart catheterization (RHC) procedure per standard of care, which will include direct PCWP and PAP measurement
    • Patient is willing to wear the CardioTag device during their RHC procedure
    Principal InvestigatorTibrewala, AnjanTibrewala, Anjan
    Location(s)
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    IRB number STU00223214
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    REVEAL AT01-301

    A Phase 3, Open-Label, Multicenter Study of I-124 evuzamitide as an Imaging Agent for the Diagnosis of Cardiac Amyloidosis using Positron Emission Tomography Computed Tomography (PET/CT)

    Eligibility Criteria
    • Is suspected of having cardiac amyloidosis and is undergoing or will undergo a diagnostic evaluation for cardiac amyloidosis (e.g., echocardiography, CMR, bone avid tracer cardiac SPECT, extracardiac or endomyocardial biopsy, etc.). Participants can be enrolled before or during their diagnostic evaluation for cardiac amyloidosis.
    • Able to undergo PET/CT imaging as part of the study, including ability to lie supine for approximately 1 hour.
    Principal InvestigatorWeinberg, Richard LawrenceWeinberg, Richard Lawrence
    ClinicalTrials.gov IdentifierNCT06788535IRB number STU00222841
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