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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
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: Crataegus Special Extract WS 1442 Phase 3

Detailed Description:
See Brief Summary

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of a Crataegus Oxycantha Extract in Chronic Heart Failure
Study Start Date : January 2000
Estimated Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343902

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00343902     History of Changes
Other Study ID Numbers: P50AT000011 ( U.S. NIH Grant/Contract )
First Posted: June 23, 2006    Key Record Dates
Last Update Posted: June 23, 2006
Last Verified: June 2006

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases