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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

University of Michigan

Information provided by:

National Center for Complementary and Integrative Health (NCCIH)

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

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Study Type :	Interventional (Clinical Trial)
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
Study Completion Date :	May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Drug Information available for: Crataegus extract

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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

Locations

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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

Investigators

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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:

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.

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

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.

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ClinicalTrials.gov Identifier:	NCT00343902
Other Study ID Numbers:	P50AT000011 ( U.S. NIH Grant/Contract ) 1999-0440
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):


Hawthorn Crataegus Herbs

Additional relevant MeSH terms:

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Heart Failure Heart Diseases Cardiovascular Diseases

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