Status:
COMPLETED
Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) Trial
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsors:
University of Michigan
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Detailed Description
See Brief Summary
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00343902
Start Date
January 1 2000
End Date
May 1 2004
Last Update
June 23 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan
Ann Arbor, Michigan, United States, 48104