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 blockWhat 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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