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NCT Number: NCT06517186

Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction

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.

Recruiting

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 1. Inadequate echo or fluoroscopic images.
  • Neck anatomy unfavorable for jugular venous cannulation
  • 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.
  • Previous or ongoing therapy with warfarin with INR ≥ 1.6 measured day before or of EMB
  • Platelet count < 50,000/ml
  • Active bleeding or coagulation disorder
  • Infection or fever
  • Endocarditis
  • Pregnancy
  • Intracardiac thrombus
  • RV Aneurysm
  • Clinically significant tricuspid, pulmonary or aortic valve stenosis
  • Tricuspid or pulmonary mechanical valve prosthesis
  • Left bundle branch block

Treatment and study plan

Primary outcomes

  1. Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF)

    Time frame: Up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Alagna

CONTACT

[email protected]

312-695-6765

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Mayo Clinic
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Pennsylvania
  • Wake Forest University Health Sciences

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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