This pilot study will evaluate the efficacy and safety of CCM therapy in heart failure patients with baseline EF≥50% (HFpEF) who have New York Heart Association (NYHA) Class II or III symptoms despite appropriate medication.
The terminology of the HF classification HFpEF is based on the 2016 European Society of Cardiology (ESC) Heart Failure Guidelines.
Who can participate
Age range40 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Baseline ejection fraction ≥ 50% (as assessed by echocardiogram within 30 days of enrollment and confirmed by the echo core laboratory).
✓. NYHA class II or III symptoms despite receiving stable optimal medical therapy (OMT) for at least 30 days based on patient's medical records (chronic stable, not transient or crescendo heart failure or angina pectoris)
✓. Stable optimal medical therapy for Heart failure for 3 months.
✓. NT-proBNP \> 220 pg/ml for subjects in sinus rhythm or \> 600 pg/ml for subjects in atrial fibrillation
✓. Has the following (as assessed by the core lab):
✓. Patient giving informed consent, willing to be available for scheduled study follow-up visits, and able to complete all testing of the study protocol
Exclusion criteria
✕. Age below 40 or greater than 80
✕. Patients with expected lifespan of less than 12 months from time of enrollment
✕. Subjects referred to an institution based on a judicial or administrative order
✕. Dilated left ventricle, as evidenced by LVEDVI \>= 97 mL/m2 (as assessed by the echo core lab)
✕. Primary cardiac valvular disease (anything more than grade 2)
✕. Congenital or untreated ischemic heart disease
✕. Infiltrative / inflammatory / genetic cardiomyopathy as documented in the medical record (e.g. amyloid, hemochromatosis, myocarditis, hypertrophic cardiomyopathy, M. Fabry, cardiac tumor), or persistent large pericardial effusion
✕. Unstable or frequent (\>1 episode/week) angina pectoris