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

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Crataegus Special Extract WS 1442
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Hawthorn, Crataegus, Herbs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Outcomes

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)

Full Information

First Posted
June 21, 2006
Last Updated
June 21, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00343902
Brief Title
Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) Trial
Official Title
Randomized Clinical Trial of a Crataegus Oxycantha Extract in Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
University of Michigan

4. Oversight

5. 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
Detailed Description
See Brief Summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Hawthorn, Crataegus, Herbs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Crataegus Special Extract WS 1442
Primary Outcome Measure Information:
Title
Distance walked on a six minute walk test at six months
Secondary Outcome Measure Information:
Title
Minnesota Living with Hearth Failure Questionnaire (Disease specific quality of life)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith D Aaronson, MD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suzanna M Zick, ND, MPH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Bolling, MD
Organizational Affiliation
University of Michigan, Department of Surgery
Official's Role
Study Director
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16230260
Citation
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.
Results Reference
background
PubMed Identifier
19789403
Citation
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.
Results Reference
derived

Learn more about this trial

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

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