drugset / Trial / NCT00343902
Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) Trial
Phase 3
Completed
120 enrolled
National Center for Complementary and Integrative Health (NCCIH)
University of Michigan · collab
RandomizedParallel-groupDouble-blindTreatment
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
Timeline
- Start
- 2000-01
- Primary completion
- —
- Completion
- 2004-05
Outcome
Missed primary endpoint
paper There were no significant differences between groups in the change in 6 min walk distance (P = 0.61) PMID 19789403 ↗
Publications
- Background 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crataegus Special Extract WS 1442 | Unknown | 450 mg | — |