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CompletedNCT00343902Updated Jun 23, 2006

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

A Phase 3 interventional study of Crataegus Special Extract WS 1442 in Chronic Heart Failure, sponsored by National Center for Complementary and Integrative Health (NCCIH). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-06-23.

Sponsored by National Center for Complementary and Integrative Health (NCCIH) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

See Brief Summary

02

Conditions studied

  • Chronic Heart Failure

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Keywords

  • Hawthorn
  • Crataegus
  • Herbs
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 120 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH) is the lead sponsor of 218 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
120 participants

Interventions

  • DrugCrataegus Special Extract WS 1442
06

What researchers measure

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)

07

Study locations

1 site
  • University of Michigan
    Ann Arbor, Michigan 48104, United States
08

References and documents

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. PubMed 16230260 ↗
  • 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. PubMed 19789403 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00343902
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
University of Michigan
First posted
Jun 23, 2006
Start date
Jan 2000
Completion
May 2004
Last update
Jun 23, 2006

Study contacts

Keith D Aaronson, MD, MS
principal investigator · University of Michigan
Suzanna M Zick, ND, MPH
principal investigator · University of Michigan
Stephen Bolling, MD
study director · University of Michigan, Department of Surgery
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2006. You cannot join it, but the record below documents what was studied.

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