Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-04-09 @ 3:02 PM
Study NCT ID:
NCT00213902
Status:
WITHDRAWN
Last Update Posted:
2007-11-29
First Post:
2005-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clonidine and Left Ventricular Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006337', 'term': 'Heart Murmurs'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'lastUpdateSubmitDate': '2007-11-28', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2007-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Heart failure', 'Diastolic', 'functionClonidine', 'Left ventricular diastolic dysfunction with preserved ejection fraction'], 'conditions': ['Ventricular Dysfunction']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are:\n\n1. To evaluate the effect of clonidine, a sympathetic modulator, to reverse cardiac remodeling and to improve hemodynamics in diastolic heart failure (DHF).\n2. To evaluate the effect of clonidine on neurohormones and quality of life in patients with DHF.\n\nThe study is a double-blind, placebo-controlled study evaluating the effects of clonidine compared to placebo in patients with DHF. A total of 70 patients with DHF will be randomized in a 1:1 ratio to:\n\n1. placebo (n=35) or to\n2. clonidine (n=35) in a dose of 0.075 mg twice a day for the first 6 weeks followed by uptitration to 0.150 mg twice a day for 6 months.\n\nThe primary outcome is the reversion of cardiac remodeling and hemodynamic parameters evaluated by magnetic resonance imaging (MRI) and echocardiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 60 and greater\n* Gender: Both\n* Patients with heart failure New York Heart Association (NYHA) II and ejection fraction over 45%'}, 'identificationModule': {'nctId': 'NCT00213902', 'briefTitle': 'Clonidine and Left Ventricular Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Evaluation of Effects of Central Sympathetic Inhibition in Elderly With Left Ventricular Diastolic Dysfunction and Preserved Ejection Fraction: A Proof-of-Concept Trial With Clonidine', 'orgStudyIdInfo': {'id': '3153'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pascal Bousquet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}}}}