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

National Institutes of Health (NIH)

Status and phase

Completed

Phase 3

Conditions

Chronic Heart Failure

Treatments

Drug: Crataegus Special Extract WS 1442

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00343902

1999-0440

P50AT000011

Details and patient eligibility

About

To determine the effect of hawthorn extract 450 mg bid vs. placebo, in addition to standard medical therapy in ambulatory patients with NYHA class II to IV chronic heart failure on submaximal exercise as measured by the 6-minute walk test

Full description

See Brief Summary

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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