Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure, Heart Failure With Preserved Ejection Fraction. Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction (MM-HFpEF) A HeartShare Clinical Study
Overview
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.
Primary outcome measures
- Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF) [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- HFpEF criteria
- Age ≥30 years.
- Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)
- Definition of HFpEF: signs and/or symptoms of HF, NYHA functional class II-IV, and at least one of the following:
- 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.
- 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).
- 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).
- Elevated H2FPEF score69 (≥5) or HFA-PEFF70 score (≥5).
Suspected HFpEF criteria
- Age ≥30 years.
- Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)
- Signs and/or symptoms of HF, NYHA functional class II-IV and all of the following:
- Does not meet BNP or NT-proBNP criteria for HFpEF (above)
- No prior HF hospitalization meeting HF criteria (above)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 6 centers
- Northwestern University — Chicago
- Johns Hopkins University — Baltimore
- Mass General Brigham — Boston
- Mayo Clinic — Rochester
- Wake Forest University — Winston-Salem
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT06517186 · 24-000688