Chronic Heart FailurePhase 3NCT00343902
Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) Trial
A Phase 3 study testing Crataegus Special Extract WS 1442 in people with Chronic Heart Failure, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Crataegus Special Extract WS 1442
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to May 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
See Brief Summary
- Conditions
- Chronic Heart Failure
- Being tested
- Crataegus Special Extract WS 1442
- Keywords
- Hawthorn, Crataegus, Herbs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crataegus Special Extract WS 1442Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2006 (estimated)
- Study startJan 2000
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Michigan
- Investigators
- Keith D Aaronson, MD, MS, Principal investigator, University of MichiganSuzanna M Zick, ND, MPH, Principal investigator, University of MichiganStephen Bolling, MD, Study director, University of Michigan, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343902
- Sponsor's protocol ID
- P50AT000011
- Other IDs
- 1999-0440
- Status last verified
- Jun 2006
- First submitted
- 21 Jun 2006
- Last updated
- 23 Jun 2006
- Results posted
- No
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 16230260Zick 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of a Crataegus Oxycantha Extract in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00343902
- Acronym / sponsor ID
- P50AT000011
- Conditions
- Chronic Heart Failure
- Keywords
- Hawthorn, Crataegus, Herbs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Collaborators
- University of Michigan
- Study start
- Jan 2000
- Study completion
- May 2004
- First posted
- 23 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crataegus Special Extract WS 1442 | Drug | – |
Primary outcome
Distance walked on a six minute walk test at six months
1 secondary outcome
Minnesota Living with Hearth Failure Questionnaire (Disease specific quality of life)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2006.
- Background: PubMed 16230260Zick 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.
- Derived from this study: PubMed 19789403Zick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Crataegus Special Extract WS 1442 in people with Chronic Heart Failure, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance walked on a six minute walk test at six months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00343902, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2006.