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NCT06517186Recruiting

Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction

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

Source: ClinicalTrials.gov · Last updated 29 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
180 (estimated)
First submitted
18 Jul 2024
Start date
8 Nov 2024
Primary completion date
Dec 2027
Lead sponsor
Northwestern University
NCT number
NCT06517186

What you commit to

  • Study type: Observational
  • Planned participants: 180
  • From 8 Nov 2024 to the primary completion date, Dec 2027
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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

Who the study is looking for

  • HFpEF criteria
    • Age ≥30 years.
    • Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)
    • Definition of HFpEF: signs and/or symptoms of HF, NYHA functional class II-IV, and at least one of the following:
    • 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.
    • 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).
    • 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).
    • Elevated H2FPEF score69 (≥5) or HFA-PEFF70 score (≥5).
    • Suspected HFpEF criteria
  • Age ≥30 years.
  • Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)
  • Signs and/or symptoms of HF, NYHA functional class II-IV and all of the following:
    • Does not meet BNP or NT-proBNP criteria for HFpEF (above)
    • No prior HF hospitalization meeting HF criteria (above)
    • No previous hemodynamic catheterization documentation of HF (as above)

Age in the registry: 30 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Johns Hopkins University
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Mass General Brigham
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
Wake Forest University
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.