An observational study in Heart Failure and Heart Failure With Preserved Ejection Fraction, sponsored by Northwestern University. Recruiting at 6 sites in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Northwestern University · Observational
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.
Adults over 30 years of age.
HFpEF criteria
Definition of HFpEF: signs and/or symptoms of HF, NYHA functional class II-IV, and at least one of the following:
Suspected HFpEF criteria
Signs and/or symptoms of HF, NYHA functional class II-IV and all of the following:
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
Participants with HFpEF
Participants without HFpEF
Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Time frame: Up to 5 years
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Northwestern University