Clinical trial NCT00343902: Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) Trial
Official title: Randomized Clinical Trial of a Crataegus Oxycantha Extract in Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Heart Failure
Keywords: Hawthorn
Crataegus
Herbs
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: University of Michigan
First posted: 2006-06-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Distance walked on a six minute walk test at six months
Secondary outcomes:
measure: Minnesota Living with Hearth Failure Questionnaire (Disease specific quality of life)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Keith D Aaronson, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Suzanna M Zick, ND, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan, Department of Surgery
name: Stephen Bolling, MD
role: STUDY_DIRECTOR
References:
citation: Zick SM, Blume A, Aaronson KD. The prevalence and pattern of complementary and alternative supplement use in individuals with chronic heart failure. J Card Fail. 2005 Oct;11(8):586-9. doi: 10.1016/j.cardfail.2005.06.427.
citation: Zick SM, Vautaw BM, Gillespie B, Aaronson KD. Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) trial. Eur J Heart Fail. 2009 Oct;11(10):990-9. doi: 10.1093/eurjhf/hfp116.