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

NCT ID: NCT00343902

Last Updated: 2006-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2004-05-31

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

Conditions

Chronic Heart Failure

Keywords

Hawthorn; Crataegus; Herbs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Crataegus Special Extract WS 1442

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: lead

Principal Investigators

Keith D Aaronson, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Suzanna M Zick, ND, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Stephen Bolling, MD

Role: STUDY_DIRECTOR

University of Michigan, Department of Surgery

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16230260 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19789403 (View on PubMed)

Other Identifiers

1999-0440

Identifier Type: -

Identifier Source: secondary_id

P50AT000011

Identifier Type: NIH

Identifier Source: org_study_id

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