Phase
Condition
Heart Failure
Chest Pain
Congestive Heart Failure
Treatment
N/AClinical Study ID
Ages > 30 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- HFpEF criteria
Age ≥30 years.
Left ventricular ejection fraction ≥50% measured by echocardiography, CMR orMUGA (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 atrialfibrillation/flutter) or NTproBNP (≥225 pg/ml in sinus rhythm or ≥675 inatrial fibrillation/flutter) at baseline. Choice of BNP or NTproBNP isbased on availability at each clinical center.
Prior HF hospitalization (primary reason for the hospitalization is HFwith elevated natriuretic peptide levels [using the thresholds listedabove], requiring IV diuresis for HF, or pulmonary edema or pulmonaryvascular congestion on chest radiography).
Previously documented elevated pulmonary capillary wedge pressure (PCWP)at rest (≥15 mmHg) or during exercise (≥25 mmHg for supine exercise orPCWP/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
Exclusion Criteria:
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 coagulationaccording to local clinical guidelines.
Previous or ongoing therapy with warfarin with INR ≥ 1.6 measured day before orof 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
Study Design
Connect with a study center
Northwestern University
Chicago, Illinois 60611
United StatesActive - Recruiting
Johns Hopkins University
Baltimore, Maryland 21287
United StatesActive - Recruiting
Mass General Brigham
Boston, Massachusetts 02114
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Wake Forest University
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
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