Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction
Recruiting now
Conditions studied: Heart Failure, Heart Failure With Preserved Ejection Fraction
In brief
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.
Key facts
- Study ID
- NCT06517186
- Run by
- Northwestern University
- People needed
- 180
- Starts
- 2024-11-08
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-04-09
Who can join
Age: 30 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 1. Inadequate echo or fluoroscopic images.
- Neck anatomy unfavorable for jugular venous cannulation
- 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.
- Previous or ongoing therapy with warfarin with INR ≥ 1.6 measured day before or of EMB
- Platelet count < 50,000/ml
- Active bleeding or coagulation disorder
- Infection or fever
- Endocarditis
- Pregnancy
- Intracardiac thrombus
- RV Aneurysm
- Clinically significant tricuspid, pulmonary or aortic valve stenosis
- Tricuspid or pulmonary mechanical valve prosthesis
- Left bundle branch block
Where it is running
- Northwestern University — Chicago, Illinois, United States (enrolling)
- Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
- Mass General Brigham — Boston, Massachusetts, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- Wake Forest University — Winston-Salem, North Carolina, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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