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NCT06517186From ClinicalTrials.govRecruiting

Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction

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

  • Heart Failure
  • Heart Failure With Preserved Ejection Fraction

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Northwestern University
Enrolment target
180
Started
8 November 2024
Main results due
December 2027
Study sites
6
Registry updated
29 September 2026

Can you take part?

  • Aged 30 years and over.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

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 sites(6)

  • Northwestern University

    Chicago, Illinois, United States

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, United States

    Recruiting

  • Mass General Brigham

    Boston, Massachusetts, United States

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, United States

    Recruiting

  • Wake Forest University

    Winston-Salem, North Carolina, United States

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, United States

    Recruiting

Showing 6 of 6 sites. 6 of the 6 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06517186. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction | Trialion