Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT00343902
Status:
COMPLETED
Last Update Posted:
2006-06-23
First Post:
2006-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'statusVerifiedDate': '2006-06', 'completionDateStruct': {'date': '2004-05'}, 'lastUpdateSubmitDate': '2006-06-21', 'studyFirstSubmitDate': '2006-06-21', 'studyFirstSubmitQcDate': '2006-06-21', 'lastUpdatePostDateStruct': {'date': '2006-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance walked on a six minute walk test at six months'}], 'secondaryOutcomes': [{'measure': 'Minnesota Living with Hearth Failure Questionnaire (Disease specific quality of life)'}]}, 'conditionsModule': {'keywords': ['Hawthorn', 'Crataegus', 'Herbs'], 'conditions': ['Chronic Heart Failure']}, 'referencesModule': {'references': [{'pmid': '16230260', 'type': 'BACKGROUND', '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.'}, {'pmid': '19789403', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'See Brief Summary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ambulatory individuals 18 years and older who had been diagnosed with CHF (NYHA functional classes II-IV) for \\> 3 months\n* Left ventricular ejection fraction (LVEF) of ≤ 40 percent\n* 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\n* 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.\n\nExclusion Criteria:\n\n* Hemodynamically severe uncorrected primary valvular disease\n* Active myocarditis\n* Hypertrophic cardiomyopathy\n* Restrictive cardiomyopathy\n* Myocardial infarction, stroke, unstable angina, coronary artery bypass graft surgery, valvular surgery, or angioplasty \\< 3 months before randomization\n* Symptomatic or sustained ventricular tachycardia not controlled by antiarrhythmic drugs or an implantable cardioverter-defibrillator\n* 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)\n* Nursing mothers, pregnant women and those planning a pregnancy during the study period'}, 'identificationModule': {'nctId': 'NCT00343902', 'briefTitle': 'Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) Trial', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Randomized Clinical Trial of a Crataegus Oxycantha Extract in Chronic Heart Failure', 'orgStudyIdInfo': {'id': 'P50AT000011', 'link': 'https://reporter.nih.gov/quickSearch/P50AT000011', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1999-0440'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Crataegus Special Extract WS 1442', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Keith D Aaronson, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Suzanna M Zick, ND, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Stephen Bolling, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Michigan, Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}, 'collaborators': [{'name': 'University of Michigan', 'class': 'OTHER'}]}}}