Heart Failure Clinical Trials

Ranked as a "High Performing" hospital by U.S. News & World Report for heart failure care, Cedars-Sinai doctors and researchers are at the forefront of advanced heart failure and cardiomyopathy diagnostic and treatment options. As a Cedars-Sinai patient, you'll have the opportunity to participate in clinical trials that may lead to better outcomes for you and millions of others.

Questions? See the Clinical Trial FAQs.

18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes

Condition: 

Aortic Stenosis

Condition: 

Amyloidosis

Key Inclusion Criteria:

  • Adult males and females listed for heart transplant at collaborating institutions
  • Diagnosed with AL or TTR amyloidosis

Summary:

The purpose of this study is to collect data (medical information) on patients with light chain (AL) and transthyreitin (TTR) amyloidosis to assess health outcomes. In so doing, researchers aim to increase their understanding of disease presentation, progression, and various treatment plans for AL and TTR cardiac amyloidosis.

Condition: 

Heart Failure

Key Inclusion Criteria:

  • 18 years of age or older
  • Ambulatory outpatients with advanced heart failure in NYHA classes II-IV, including patients with ventricular assist devices, that are referred for bariatric surgery
  • Stable medical regimen (except for adjustment in diuretic dosing) for the past month
  • Body mass index ≥ 35 kg/m2
  • Ejection fraction ≤ 40% assessed within the past 6 months

Summary:

The purpose of this study is to collect information to learn more about outcomes in heart failure patients undergoing bariatric surgery. Participants will be asked to complete a questionnaire. Researchers will use this information to confirm that bariatric surgery, a surgery for weight loss, is safe and effective in patients with heart failure.

Key Inclusion Criteria:

  • Patients with cardiovascular disease who are identified by their treating physicians and referred to the study

Summary:

This study will examine heart tissue samples from individuals whose treating physician has recommended cardiac surgery for coronary bypass, or to repair or replace a heart valve for clinically indicated purposes. The purpose of the study is to learn more about a newly discovered type of heart stem cell. Researchers will examine these cells to determine whether they have the ability to grow and improve the heart function of damaged hearts. The study also aims to learn more about newly discovered spherical clusters of these heart stem cells known as cardiospheres.

Condition: 

Heart Failure

Key Inclusion Criteria:

  • At least 18 years old
  • Heart failure, post-heart transplant patients, or normal controls (healthy subjects with no known heart disease) cared for by the Advanced Heart Disease Team at Cedars-Sinai Heart Institute

Summary:

The purpose of this study is to collect blood and tissue samples in a centralized bank that can be used for investigations. Participants have either been diagnosed with heart failure or may participate as a healthy volunteer.

Condition: 

Coronary artery disease, peripheral vascular disease, cancers

Key Inclusion Criteria:

  • At least 18 years old with body mass index less than 30
  • Diagnosed with or undergoing evaluation for cardiovascular, nervous system diseases or solid-organ cancers

Summary:

Using the hybrid Siemens Biograph mMr (PET-MR) scanner, researchers simultaneously acquire MR and PET data across the whole body. Biomedical Imaging Research Institute scientists focus on developing new imaging techniques to answer a wide array of research and clinical questions, where producing a single scan that reveals both functional and anatomical information would create a more complete diagnostic tool. In collaboration with medical specialists, pulse sequences (software) are validated in patients undergoing evaluation for numerous diseases, including many types of heart disease, peripheral and intracranial (brain) neurological diseases, cancers, spine problems, urology and other nervous system disorders. The long-term goal of this study is to develop new techniques that would translate to clinical significance.

Condition:

Coronary Artery Disease

Key Inclusion Criteria:

  • Participants enrolled and to be enrolled in Barbra Streisand Women’s Heart Center research studies 

Summary:

The purpose of this study is to collect long-term data and blood and urine samples to further understand heart artery disease. In so doing, researchers aim to identify biomarker and genetic factors that influence heart arteries. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease. Participants will be contacted annually to complete a phone interview about topics such as clinical symptoms, medications, quality of life, hospitalizations, myocardial infarction (heart attack) and stroke.

Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study (PRELUDE)

Condition: 

Mitral Valve Regurgitation

CardiAMP™ Heart Failure Trial

Condition: 

Heart failure

Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) (COAPT)

Condition: 

Mitral Regurgitation, Mitral Valve Regurgitation, Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects, Heart Failure

The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study (CLASP)

Condition: 

Mitral Valve Regurgitation

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT)

Condition: 

Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency, Cardiovascular Diseases, Valve Disease (Heart), Heart Valve Diseases, Functional Mitral Regurgitation, Degenerative Mitral Valve Disease

Edwards Cardioband System ACTIVE Pivotal Clinical Trial

Condition: 

Functional Mitral Regurgitation, Mitral Regurgitation, Mitral Insufficiency

Edwards EVOQUE TMVR Early Feasibility Study

Condition: 

Mitral Valve Regurgitation (Degenerative or Functional)

Condition: 

Atherosclerotic cardiovascular disease, hypercholesterolemia

Key Inclusion Criteria:

  • Evidence by cardiac computed tomography angiography of noncalcified coronary artery plaque and thoracic aorta atherosclerosis 
  • Indications for evolocumab treatment

Summary:

This study focuses on patients who have clinical atherosclerotic cardiovascular disease (ASCVD) or high cholesterol levels and are allergic to statins, or who have been diagnosed with primary hypercholesterolemia or homozygous familial hypercholesterolemia (genetic disorder causing high cholesterol levels and early heart disease). The purpose of the study is to evaluate the changes, if any, in coronary plaque volumes and its composition in patients who are treated with a drug called evolocumab. To help evaluate the effect of evolocumab, researchers will ask patients who are scheduled to start taking evolocumab plus another cholesterol-lowering medication (such as a statin) to undergo diagnostic testing, including non-invasive coronary computed tomography angiography scans and positron emission tomography (PET) scans.

EntrestoTM (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)

Condition: 

Heart Failure

Condition: 

Coronary artery disease

Key Inclusion Criteria:

  • At least 18 years old
  • Scheduled to undergo an invasive coronary angiography for the assessment of coronary artery disease at the time of enrollment
  • Signed consent form and willing to allow researchers to make medical records available to GE Healthcare

Summary:

This study focuses on patients who are scheduled to have an invasive coronary angiography (cardiac catheterization) as part of their standard of care. The purpose of the study is to evaluate how well an investigational imaging drug called flurpiridaz (F-18) can detect coronary artery disease. Coronary artery disease is a condition that decreases blood flow to the heart.

Condition: 

Hereditary heart disease

Key Inclusion Criteria:

  • Affected and unaffected family members from subjects with: Wolff-Parkinson-White syndrome, Brugada syndrome, idiopathic ventricular tachycardia and fibrillation, long QT syndrome, hypertrophic, dilated and restrictive cardiomyopathy, and supraventricular tachycardia

Summary:

This study focuses on individuals who have a hereditary form of heart disease, which may have occurred in isolated individuals or through inheritance, affecting multiple family members. The purpose of the study is to find the particular gene that causes the inherited form of heart disease. The study aims to obtain information on heart-related symptoms and genetic makeup, as well as those of family members who are either healthy or have heart disease.

A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM

Condition: 

Hypertrophic Cardiomyopathy, Obstructive Hypertrophic Cardiomyopathy, Non-obstructive Hypertrophic Cardiomyopathy

Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

Condition: 

Transthyretin (TTR) Amyloid Cardiomyopathy

Condition: 

Atherosclerosis

Key Inclusion Criteria:

  • Recent myocardial infarction, ischemic stroke, or onset of symptomatic lower extremity peripheral artery disease less than 3 months before study enrollment
  • Recent or planned prescription of statin and antiplatelet therapy within 3 months of study recruitment

Summary:

This study focuses on patients who have recently had a heart attack, stroke or symptomatic peripheral artery disease. The purpose of the study is to measure plaque in multiple arteries in the body and evaluate their characteristics. Researchers will obtain these measurements to examine the ability of magnetic resonance imaging (MRI) to assess cardiovascular risk. Participants will undergo MRI of the carotid, coronary and femoral arteries; pulse wave analysis (a noninvasive clinical test) to measure stiffness of the blood vessels; and blood collection. They will also be asked to complete questionnaires.

The PARTNER 3 - Trial - The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis (P3)

Condition: 

Aortic Stenosis

Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment

Condition: 

Cardiovascular Disease, Atherosclerosis

Real World Expanded Multicenter Study of the MitraClip® System (REALISM)

Condition: 

Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency

Reducing Lung CongestIon Symptoms in Advanced Heart Failure (RELIEVE-HF)

Condition: 

Heart Failure

Condition: 

Heart Failure

Key Inclusion Criteria:

  • Patients with advanced heart disease

Summary:

The purpose of this data collection registry is to examine how various factors, such as medical history and medical therapy, affect short-term and long-term outcomes in advanced heart disease (AHD). Researchers will collect data from medical records of AHD patients to monitor outcomes and improve treatment. Through this registry, investigators intend to compile life histories of advanced heart failure patients in an effort to document the evolving understanding of risk factors and outcomes in the AHD population.

Safety and Potential Bioactivity of CLBS14 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease

Condition: 

Coronary Microvascular Dysfunction

Condition:

Takotsubo Syndrome

Key Inclusion Criteria:

  • Diagnosis of Takotsubo syndrome
  • Submission of required medical records

Summary:

The goal of this registry is to understand how widespread Takotsubo is and to determine which individuals are at risk of experiencing additional Takotsubo events or other health problems. Registry participants will also be invited to provide a blood sample which will undergo proteomics analysis (study of proteins in the blood). Analysis of the registry's medical information and proteomics findings will enable researchers to study Takotsubo's effects on the body and determine potential treatment targets that can lead to new therapeutic strategies.

Supporting Patients Undergoing High-Risk PCI Using a High-Flow Percutaneous Left Ventricular Support Device (SHIELD II)

Condition: 

Coronary Artery Disease

Condition: 

Heart Failure

Key Inclusion Criteria:

  • At imminent risk of death from biventricular heart failure
  • Two functional atrioventricular valves
  • Body surface area of 1.2m2 through 1.85 m2
  • Adequate sternum to T10 distance OR adequate room in chest

Summary:

The purpose of this study is to evaluate whether the Syncardia 50cc Temporary Total Artificial Heart (TAH-T) can support patients who are eligible for heart transplantation and for whom another model of the device (70cc TAH-T) is not appropriate due to the size of the chest cavity (i.e., it would not fit safely in the chest). The device is designed as a bridge (temporary solution) to transplant for patients who are at risk of imminent death due to irreversible, complete heart failure while waiting for a donor heart.

Condition: 

Heart Failure

Key Inclusion Criteria (for primary group):

  • Life-threatening, irreversible biventricular heart failure
  • Ineligible for cardiac transplantation as determined by the implanting center at time of implant screening assessment
  • Ambulatory without assistance
  • 19-75 years old

Summary:

The purpose of this study is to test the investigational use of the SynCardia 70cc Temporary Total Artificial Heart (TAH-T) as a permanent option for the treatment of biventricular heart failure in patients who are not currently eligible for heart transplantation. Researchers will evaluate whether the TAH-T can support patients with life-threatening, irreversible heart failure who are not candidates for a left ventricular assist device and have no other viable treatment options.

Transcatheter Aortic Valve Replacement to Unload the Left Ventricle in Patients With Advanced Heart Failure (TAVR UNLOAD)

Condition: 

Aortic Valve Stenosis

Condition: 

Cardiovascular disease

Key Inclusion Criteria:

For women undergoing invasive coronary angiography:

  • At least 18 years old
  • Symptomatic angina or anginal equivalent

For women and men with HFpEF:

  • At least 18 years old
  • Symptoms of heart failure
  • Preserved ejection fraction, left ventricular ejection fraction ≥45% prior to study entry

Summary:

This study focuses on women undergoing clinically-ordered coronary angiography for suspected coronary microvascular dysfunction (small vessel disease), or men or women with heart failure with preserved ejection fraction (HFpEF). Researchers aim to better understand HFpEF (inadequate heart muscle function in the setting of preserved muscle pumping) for therapeutic strategy development and optimized noninvasive cardiac MRI for the diagnosis and management of coronary microvascular dysfunction and HFpEF.

Women's Heart Attack Research Program—Imaging Study (HARP)

Condition:

Myocardial Infarction