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RecruitingNCT06517186Updated Sep 29, 2026

Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction

An observational study in Heart Failure and Heart Failure With Preserved Ejection Fraction, sponsored by Northwestern University. Recruiting at 6 sites in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Northwestern University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
30 Years and older
Sex
All
01

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.

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Conditions studied

  • Heart Failure
  • Heart Failure With Preserved Ejection Fraction

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Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults over 30 years of age.

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

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (estimated)
Target follow-up
4 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • HFpEF

    Participants with HFpEF

  • Non-HFpEF

    Participants without HFpEF

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What researchers measure

Primary outcomes

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

    Time frame: Up to 5 years

06

Study locations

6 of 6 sites recruiting
  • Northwestern University
    Chicago, Illinois 60611, United States
    • Laura Alagna · Contact · laura.alagna@northwestern.edu · 312-695-6765
    • Sadiya Khan, MD · Principal investigator
    • Laura Rasussen-Torvik, PhD, MPH · Principal investigator
    Recruiting
  • Johns Hopkins University
    Baltimore, Maryland 21287, United States
    • Matt Kauffman · Contact · mkkauffman@jhmi.edu
    • Kavita Sharma, MD · Principal investigator
    • David Kass, MD · Sub investigator
    Recruiting
  • Mass General Brigham
    Boston, Massachusetts 02114, United States
    • Diane Cocca-Spofford · Contact · dcoccaspofford@mgh.harvard.edu · 617-726-8228
    • Greg Lewis, MD · Principal investigator
    • Akshay Desai, MD, MPH · Sub investigator
    • Michael Givertz, MD · Sub investigator
    • Scott Solomon, MD · Sub investigator
    Recruiting
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    • Brendon Urena · Contact · urena.brendon@mayo.edu · 507-538-8305
    • Margaret Redfield, MD · Principal investigator
    • Borlaug Barry, MD · Sub investigator
    Recruiting
  • Wake Forest University
    Winston-Salem, North Carolina 27157, United States
    • Ben Nelson · Contact · 336-716-6789
    • Dalane Kitzman, MD · Principal investigator
    • Alain Bertoni, MD, MPH · Sub investigator
    Recruiting
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
    • Tiffany Sharkoski · Contact · 215-615-2354
    • Julio Chirinos, MD, PhD · Principal investigator
    Recruiting
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References and documents

Study documents

  • Study protocol · Feb 19, 2024

Documents are hosted by the registry — open the source record to download them.

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Registry details

Key details

Study ID
NCT06517186
Lead sponsor
Northwestern University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Massachusetts General Hospital, Brigham and Women's Hospital, Mayo Clinic, Wake Forest University Health Sciences, University of Pennsylvania
Responsible party
Sanjiv Shah (Stone Endowed Professor of Medicine, Director of Research, Bluhm Cardiovascular Institute, Principal Investigator, HeartShare Data Translation Center, Northwestern University) — Principal investigator
First posted
Jul 24, 2024
Start date
Nov 8, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Laura Alagna
Contact
heartsharestudy@northwestern.edu
312-695-6765
Sanjiv Shah, MD
principal investigator · Northwestern University
Margaret Redfield, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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