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

June 21, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See Brief Summary

Study Type

Interventional

Enrollment

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Distance walked on a six minute walk test at six months

Secondary Outcome Measures

Outcome Measure
Minnesota Living with Hearth Failure Questionnaire (Disease specific quality of life)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborators

University of Michigan

Investigators

  • Principal Investigator: Keith D Aaronson, MD, MS, University of Michigan
  • Study Director: Stephen Bolling, MD, University of Michigan, Department of Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Study Completion

May 1, 2004

Study Registration Dates

First Submitted

June 21, 2006

First Submitted That Met QC Criteria

June 21, 2006

First Posted (ESTIMATE)

June 23, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 23, 2006

Last Update Submitted That Met QC Criteria

June 21, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P50AT000011 (NIH)
  • 1999-0440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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