Actively Recruiting

Age: 30Years +
All Genders
Healthy Volunteers
NCT06517186

Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction

Led by Northwestern University · Updated on 2026-04-09

180

Participants Needed

6

Research Sites

107 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial 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

Official Title

Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction

Who Can Participate

Age: 30Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 30 years or older
  • Left ventricular ejection fraction 50% or higher measured by echocardiography, CMR, or MUGA within one year with clinical stability
  • Signs or symptoms of heart failure with NYHA functional class II-IV
  • Elevated BNP or NT-proBNP levels based on specific thresholds or prior heart failure hospitalization with elevated natriuretic peptides
  • Documented elevated pulmonary capillary wedge pressure at rest or during exercise, or elevated H2FPEF or HFA-PEFF scores
  • For suspected HFpEF: age 30 years or older, left ventricular ejection fraction 50% or higher, signs or symptoms of heart failure with NYHA class II-IV, and not meeting BNP/NT-proBNP or hospitalization criteria
Not Eligible

You will not qualify if you...

  • Inadequate echocardiogram or fluoroscopic images
  • Unfavorable neck anatomy for jugular venous cannulation
  • Current therapy with direct oral anticoagulants without adequate cessation
  • Current or recent warfarin therapy with INR 1.6 or higher at biopsy
  • Platelet count below 50,000/ml
  • Active bleeding or coagulation disorder
  • Infection or fever
  • Endocarditis
  • Pregnancy
  • Intracardiac thrombus
  • Right ventricular aneurysm
  • Significant valve stenosis of tricuspid, pulmonary, or aortic valves
  • Mechanical valve prosthesis in tricuspid or pulmonary position
  • Left bundle branch block

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

2

Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

3

Mass General Brigham

Boston, Massachusetts, United States, 02114

Actively Recruiting

4

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

5

Wake Forest University

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

6

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

L

Laura Alagna

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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