Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction

April 8, 2026 updated by: Sanjiv Shah, Northwestern University

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Sadiya Khan, MD
        • Contact:
        • Principal Investigator:
          • Laura Rasussen-Torvik, PhD, MPH
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Kavita Sharma, MD
        • Contact:
        • Sub-Investigator:
          • David Kass, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Mass General Brigham
        • Principal Investigator:
          • Greg Lewis, MD
        • Contact:
        • Sub-Investigator:
          • Akshay Desai, MD, MPH
        • Sub-Investigator:
          • Michael Givertz, MD
        • Sub-Investigator:
          • Scott Solomon, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Margaret Redfield, MD
        • Sub-Investigator:
          • Borlaug Barry, MD
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University
        • Contact:
          • Ben Nelson
          • Phone Number: 336-716-6789
        • Principal Investigator:
          • Dalane Kitzman, MD
        • Sub-Investigator:
          • Alain Bertoni, MD, MPH
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
          • Tiffany Sharkoski
          • Phone Number: 215-615-2354
        • Principal Investigator:
          • Julio Chirinos, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults over 30 years of age.

Description

Inclusion Criteria:

  • 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. Definition of HFpEF: signs and/or symptoms of HF, NYHA functional class II-IV, and at least one of the following:

      1. 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.
      2. 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).
      3. 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).
      4. 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:

    1. Does not meet BNP or NT-proBNP criteria for HFpEF (above)
    2. No prior HF hospitalization meeting HF criteria (above)
    3. No previous hemodynamic catheterization documentation of HF (as above)

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HFpEF
Participants with HFpEF
Non-HFpEF
Participants without HFpEF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

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

Investigators

  • Principal Investigator: Sanjiv Shah, MD, Northwestern University
  • Principal Investigator: Margaret Redfield, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-000688

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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