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

Northwestern University7 sites in 1 country180 target enrollmentNovember 8, 2024

ConditionsHeart Failure Heart Failure With Preserved Ejection Fraction

Overview

Phase: Not Applicable
Intervention: HFpEF
Conditions: Heart Failure
Sponsor: Northwestern University
Enrollment: 180
Locations: 7
Primary Endpoint: Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Status: Recruiting
Last Updated: 23 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 8, 2024

End Date

December 1, 2026

Last Updated

23 days ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Northwestern University

Responsible Party

Principal Investigator

Sanjiv Shah

Stone Endowed Professor of Medicine, Director of Research, Bluhm Cardiovascular Institute, Principal Investigator, HeartShare Data Translation Center

Northwestern University

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.

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