180 Participants Needed

Heart Biopsy for Heart Failure

Recruiting at 5 trial locations
LA
Overseen ByLaura Alagna
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study heart tissue changes in individuals with heart failure to aid in developing new treatments. It involves a heart biopsy, where a small tissue sample is taken during a procedure called right heart catheterization. Suitable candidates for this trial have symptoms of heart failure and a history of the condition, such as frequent shortness of breath or swelling, but maintain normal heart pumping function.

As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to potentially groundbreaking heart failure therapies.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover the specific myocardial mechanisms involved in heart failure with preserved ejection fraction (HFpEF), a condition for which current treatments often provide limited relief. Unlike other trials that focus on testing new medications, this study dives deep into understanding how the heart's muscles and functions contribute to HFpEF. By identifying these unique mechanisms, the trial could pave the way for developing more targeted therapies that address the root causes of the condition, potentially offering more effective solutions for patients in the future.

Who Is on the Research Team?

SS

Sanjiv Shah, MD

Principal Investigator

Northwestern University

MR

Margaret Redfield, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

My heart pumps well but is stiff (HFpEF).
My heart failure markers are above normal levels.
I was hospitalized for heart failure, needed IV diuresis, or had lung congestion on an X-ray.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo an endomyocardial biopsy (EMB) during a right heart catheterization (RHC) to identify changes in heart tissue structure and biological function

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Brigham and Women's Hospital

Collaborator

Trials
1,694
Recruited
14,790,000+

University of Pennsylvania

Collaborator

Trials
2,118
Recruited
45,270,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

Mayo Clinic

Collaborator

Trials
3,427
Recruited
3,221,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Wake Forest University Health Sciences

Collaborator

Trials
1,432
Recruited
2,506,000+
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