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

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ClinicalTrials.gov Identifier: NCT00343902
Recruitment Status : Completed
First Posted : June 23, 2006
Last Update Posted : June 23, 2006
Sponsor:
Collaborator:
University of Michigan
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

June 21, 2006
June 23, 2006
June 23, 2006
January 2000
Not Provided
Distance walked on a six minute walk test at six months
Same as current
No Changes Posted
Minnesota Living with Hearth Failure Questionnaire (Disease specific quality of life)
Same as current
Not Provided
Not Provided
 
Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) Trial
Randomized Clinical Trial of a Crataegus Oxycantha Extract in Chronic Heart Failure
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
See Brief Summary
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Chronic Heart Failure
Drug: Crataegus Special Extract WS 1442
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
Same as current
May 2004
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00343902
P50AT000011( U.S. NIH Grant/Contract )
1999-0440
Not Provided
Not Provided
Not Provided
Not Provided
National Center for Complementary and Integrative Health (NCCIH)
University of Michigan
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
National Center for Complementary and Integrative Health (NCCIH)
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP