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

Chronic Heart Failure Clinical Trial

Official title:

Randomized Clinical Trial of a Crataegus Oxycantha Extract in Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343902
• Other study ID #: P50AT000011
• Secondary ID: 1999-0440
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2006
• Last updated: June 21, 2006
• Start date: January 2000
• Est. completion date: May 2004

Study information

• Verified date: June 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

See Brief Summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• Crataegus Special Extract WS 1442

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)	University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance walked on a six minute walk test at six months
Secondary	Minnesota Living with Hearth Failure Questionnaire (Disease specific quality of life)