Heart Failure, Heart Failure With Preserved Ejection Fraction
Conditions
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.
Interventions
None listed
Sponsors
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Massachusetts General Hospital
Brigham and Women's Hospital
Mayo Clinic
Wake Forest University Health Sciences
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* HFpEF criteria 1. Age ≥30 years. 2. Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability) 3. Definition of HFpEF: signs and/or symptoms of HF, NYHA functional class II-IV, and at least one of the following: 1. 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. 2. 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). 3. 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). 4. Elevated H2FPEF score69 (≥5) or HFA-PEFF70 score (≥5). Suspected HFpEF criteria 1. Age ≥30 years. 2. Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability) 3. Signs and/or symptoms of HF, NYHA functional class II-IV and all of the following: 1. Does not meet BNP or NT-proBNP criteria for HFpEF (above) 2. No prior HF hospitalization meeting HF criteria (above) 3. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF) | Up to 5 years |
Countries
United States
Contacts
CONTACTLaura Alagna
PRINCIPAL_INVESTIGATORSanjiv Shah, MD
Northwestern University
PRINCIPAL_INVESTIGATORMargaret Redfield, MD
Mayo Clinic
Outcome results
None listed