Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction
Northwestern University · with National Heart, Lung, and Blood Institute (NHLBI), Massachusetts General Hospital · NCT06517186
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 30+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 180
- US sites recruiting
- 6
- Study start
- November 8, 2024
- Record last updated
- September 29, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Conditions: Heart Failure; Heart Failure With Preserved Ejection Fraction
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
- 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
Recruiting US locations
Northwestern University
Chicago, IL 60611
Site contact: Laura Alagna · 312-695-6765 · laura.alagna@northwestern.edu
Johns Hopkins University
Baltimore, MD 21287
Site contact: Matt Kauffman · mkkauffman@jhmi.edu
Mass General Brigham
Boston, MA 02114
Site contact: Diane Cocca-Spofford · 617-726-8228 · dcoccaspofford@mgh.harvard.edu
Mayo Clinic
Rochester, MN 55905
Site contact: Brendon Urena · 507-538-8305 · urena.brendon@mayo.edu
Wake Forest University
Winston-Salem, NC 27157
Site contact: Ben Nelson · 336-716-6789
University of Pennsylvania
Philadelphia, PA 19104
Site contact: Tiffany Sharkoski · 215-615-2354
Study contacts (from the official record)
- Laura Alagna · 312-695-6765 · heartsharestudy@northwestern.edu
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