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Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction

Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction (MM-HFpEF) A HeartShare Clinical Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The purpose of this study is to identify changes in heart tissue structure and biological function in patients with heart failure by performing an endomyocardial biopsy (EMB or heart biopsy) during a right heart catheterization (RHC)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks for changes in heart tissue in people with known or suspected heart failure whose hearts still pump out a normal share of blood. Doctors take a small piece of heart tissue during a test that uses a thin tube to check the right side of the heart. The goal is to help develop new heart failure treatments.

The purpose of this study is to identify changes in heart tissue structure and biological function in patients with heart failure by performing an endomyocardial biopsy (EMB or heart biopsy) during a right heart catheterization (RHC). The ultimate goal is to use this information to develop new treatments for heart failure.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 30 or older.
  • A heart scan within the past year shows an ejection fraction of at least 50%. This means the heart pumps out at least half the blood in its main pumping chamber with each beat. Your condition must also be stable.
  • You have heart failure signs or symptoms that limit activity or occur at rest.
  • For known heart failure, you must have at least one of these: high levels of heart strain markers in blood, a qualifying past heart failure hospital stay, high heart filling pressure on a past test, or a high score on certain heart failure rating tools.
  • For suspected heart failure, your blood markers must be below the study's cutoffs, with no qualifying past heart failure hospital stay and no past heart tube test confirming high filling pressure.

Who can't join

  • Heart ultrasound or X-ray images are not clear enough, or your neck makes it hard to safely place a tube into a neck vein.
  • You take a direct oral blood thinner and have not stopped it long enough under local medical guidelines, or you have used warfarin and your INR blood-clotting test is 1.6 or higher just before the biopsy.
  • Your platelet count is below 50,000/ml, you have active bleeding, or you have a blood-clotting disorder. Platelets help blood clot.
  • You have an infection, fever, or an infection of the heart's inner lining.
  • You are pregnant.
  • You have a blood clot inside the heart or a bulge in the wall of its lower right chamber.
  • You have major narrowing of the tricuspid, pulmonary, or aortic heart valve, or a mechanical replacement tricuspid or pulmonary valve.
  • You have left bundle branch block, a problem with the heart's electrical signals.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * HFpEF criteria 1. Age ≥30 years. 2. Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability) 3. Definition of HFpEF: signs and/or symptoms of HF, NYHA functional class II-IV, and at least one of the following: 1. Elevated BNP (≥75 pg/ml in sinus rhythm or ≥225 pg/ml in atrial fibrillation/flutter) or NTproBNP (≥225 pg/ml in sinus rhythm or ≥675 in atrial fibrillation/flutter) at baseline. Choice of BNP or NTproBNP is based on availability at each clinical center. 2. Prior HF hospitalization (primary reason for the hospitalization is HF with elevated natriuretic peptide levels \[using the thresholds listed above\], requiring IV diuresis for HF, or pulmonary edema or pulmonary vascular congestion on chest radiography). 3. Previously documented elevated pulmonary capillary wedge pressure (PCWP) at rest (≥15 mmHg) or during exercise (≥25 mmHg for supine exercise or PCWP/cardiac output ratio ≥2 mmHg/L/min for upright exercise). 4. Elevated H2FPEF score69 (≥5) or HFA-PEFF70 score (≥5). Suspected HFpEF criteria 1. Age ≥30 years. 2. Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability) 3. Signs and/or symptoms of HF, NYHA functional class II-IV and all of the following: 1. Does not meet BNP or NT-proBNP criteria for HFpEF (above) 2. No prior HF hospitalization meeting HF criteria (above) 3. No previous hemodynamic catheterization documentation of HF (as above) Exclusion Criteria: * 1\. Inadequate echo or fluoroscopic images. 2\. Neck anatomy unfavorable for jugular venous cannulation 3\. Therapy with direct oral anticoagulants without cessation for a period (age, renal function, and agent specific) deemed adequate to normalize coagulation according to local clinical guidelines. 4\. Previous or ongoing therapy with warfarin with INR ≥ 1.6 measured day before or of EMB 5\. Platelet count \< 50,000/ml 6\. Active bleeding or coagulation disorder 7\. Infection or fever 8\. Endocarditis 9\. Pregnancy 10\. Intracardiac thrombus 11\. RV Aneurysm 12\. Clinically significant tricuspid, pulmonary or aortic valve stenosis 13\. Tricuspid or pulmonary mechanical valve prosthesis 14\. Left bundle branch block

Study sites (6)

IL

MA

MD

MN

NC

  • Wake Forest University · Winston-Salem, NC 27157Ben Nelson · Study contact · 336-716-6789Dalane Kitzman, MD · Principal investigatorAlain Bertoni, MD, MPH · Sub-investigatorMore trials in Winston-Salem

PA