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

This study has been completed.
Sponsor:
Collaborator:
University of Michigan
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00343902
First received: June 21, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

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


Condition Intervention Phase
Chronic Heart Failure
 Drug: Crataegus Special Extract WS 1442
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of a Crataegus Oxycantha Extract in Chronic Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Distance walked on a six minute walk test at six months

Secondary Outcome Measures:
  • Minnesota Living with Hearth Failure Questionnaire (Disease specific quality of life)

Estimated Enrollment: 120
Study Start Date: January 2000
Estimated Study Completion Date: May 2004
Detailed Description:

See Brief Summary

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343902

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
National Center for Complementary and Alternative Medicine (NCCAM)
University of Michigan
Investigators
Principal Investigator: Keith D Aaronson, MD, MS University of Michigan
Principal Investigator: Suzanna M Zick, ND, MPH University of Michigan
Study Director: Stephen Bolling, MD University of Michigan, Department of Surgery
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00343902     History of Changes
Other Study ID Numbers: P50 AT000011, 1999-0440
Study First Received: June 21, 2006
Last Updated: June 21, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Hawthorn
Crataegus
Herbs

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013