Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction

Last updated: November 14, 2024
Sponsor: Northwestern University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT06517186
24-000688
  • Ages > 30
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • HFpEF criteria
  1. Age ≥30 years.

  2. Left ventricular ejection fraction ≥50% measured by echocardiography, CMR orMUGA (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:

  4. Elevated BNP (≥75 pg/ml in sinus rhythm or ≥225 pg/ml in atrialfibrillation/flutter) or NTproBNP (≥225 pg/ml in sinus rhythm or ≥675 inatrial fibrillation/flutter) at baseline. Choice of BNP or NTproBNP isbased on availability at each clinical center.

  5. Prior HF hospitalization (primary reason for the hospitalization is HFwith elevated natriuretic peptide levels [using the thresholds listedabove], requiring IV diuresis for HF, or pulmonary edema or pulmonaryvascular congestion on chest radiography).

  6. Previously documented elevated pulmonary capillary wedge pressure (PCWP)at rest (≥15 mmHg) or during exercise (≥25 mmHg for supine exercise orPCWP/cardiac output ratio ≥2 mmHg/L/min for upright exercise).

  7. 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:

  4. Does not meet BNP or NT-proBNP criteria for HFpEF (above)

  5. No prior HF hospitalization meeting HF criteria (above)

  6. No previous hemodynamic catheterization documentation of HF (as above)

Exclusion

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 coagulationaccording to local clinical guidelines.

  4. Previous or ongoing therapy with warfarin with INR ≥ 1.6 measured day before orof 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 Design

Total Participants: 180
Study Start date:
November 08, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Mass General Brigham

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Wake Forest University

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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