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

NCT00343902 | Completed Phase 3

• 2 other identifiers: P50AT0000111999-0440
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Heart Failure

Keywords

Hawthorn; Crataegus; Herbs

Outcome Measures

Primary Outcomes (1)

• Distance walked on a six minute walk test at six months

Secondary Outcomes (1)

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

Interventions

Crataegus Special Extract WS 1442 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead
• University of Michigan: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (2)

• 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.

  PMID: 16230260 BACKGROUND

• 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.

  PMID: 19789403 DERIVED

Study Officials

• Keith D Aaronson, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Suzanna M Zick, ND, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Stephen Bolling, MD

  University of Michigan, Department of Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 21, 2006
• First Posted: June 23, 2006
• Study Start: January 1, 2000
• Study Completion: May 1, 2004
• Last Updated: June 23, 2006

Record last verified: 2006-06

Locations

US (1)