Chronic Heart Failure
Conditions
Keywords
Hawthorn, Crataegus, Herbs
Brief summary
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
Detailed description
See Brief Summary
Interventions
DRUGCrataegus Special Extract WS 1442
Sponsors
University of Michigan
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distance walked on a six minute walk test at six months | — |
Secondary
| Measure | Time frame |
|---|---|
| Minnesota Living with Hearth Failure Questionnaire (Disease specific quality of life) | — |
Countries
United States
Outcome results
None listed