Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) Trial

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Inclusion criteria

• Ambulatory individuals 18 years and older who had been diagnosed with CHF (NYHA functional classes II-IV) for > 3 months
• Left ventricular ejection fraction (LVEF) of ≤ 40 percent
• Receiving indicated standard therapy (if not contraindicated or intolerant for > 3 months) defined as a diuretic, an ACE-inhibitor or an angiotensin receptor blocker (ARB) and a beta-blocke
• Patients with NYHA class III or IV symptoms were also required to receive spironolactone. Doses of these drugs had to be stable for ≥ 3 months, except for diuretics, for which ≥ 1 month of stability was required.

Exclusion criteria

• Hemodynamically severe uncorrected primary valvular disease
• Active myocarditis
• Hypertrophic cardiomyopathy
• Restrictive cardiomyopathy
• Myocardial infarction, stroke, unstable angina, coronary artery bypass graft surgery, valvular surgery, or angioplasty < 3 months before randomization
• Symptomatic or sustained ventricular tachycardia not controlled by antiarrhythmic drugs or an implantable cardioverter-defibrillator
• Any condition other than heart failure that would be expected to limit exercise (e.g., angina, peripheral vascular disease, pulmonary disease, arthritis, or an orthopedic problem severe enough to limit exercise)
• Nursing mothers, pregnant women and those planning a pregnancy during the study period