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Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction

Northwestern University · with National Heart, Lung, and Blood Institute (NHLBI), Massachusetts General Hospital · NCT06517186

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 30+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
180
US sites recruiting
6
Study start
November 8, 2024
Record last updated
September 29, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Conditions: Heart Failure; Heart Failure With Preserved Ejection Fraction

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Northwestern University

    Chicago, IL 60611

    Site contact: Laura Alagna · 312-695-6765 · laura.alagna@northwestern.edu

  • Johns Hopkins University

    Baltimore, MD 21287

    Site contact: Matt Kauffman · mkkauffman@jhmi.edu

  • Mass General Brigham

    Boston, MA 02114

    Site contact: Diane Cocca-Spofford · 617-726-8228 · dcoccaspofford@mgh.harvard.edu

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: Brendon Urena · 507-538-8305 · urena.brendon@mayo.edu

  • Wake Forest University

    Winston-Salem, NC 27157

    Site contact: Ben Nelson · 336-716-6789

  • University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Tiffany Sharkoski · 215-615-2354

Study contacts (from the official record)

  • Laura Alagna · 312-695-6765 · heartsharestudy@northwestern.edu
Myocardial Mechanisms in Heart Failure With Preserved Ejection… (NCT06517186) | Bored Studies