Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-29 @ 12:44 AM
Study NCT ID:
NCT01127334
Status:
WITHDRAWN
Last Update Posted:
2012-04-04
First Post:
2010-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study Using Echocardiography to Evaluate Patients With Heart Failure and Dyssynchrony Who Have a CRT-D Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054143', 'term': 'Heart Failure, Systolic'}], 'ancestors': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Principal Investigator terminated study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-02', 'studyFirstSubmitDate': '2010-05-19', 'studyFirstSubmitQcDate': '2010-05-19', 'lastUpdatePostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dyssynchrony', 'Cardiac resynchronization therapy'], 'conditions': ['Systolic Heart Failure']}, 'descriptionModule': {'briefSummary': 'Out of all the patients that receive a CRT-D ( a dual chamber pacemaker with defibrillator ) for cardiac resynchronization therapy there is approximately one-third that do not respond. We believe that by using a simple technique that includes routine echocardiography that are normally performed in these patients could help us better understand how to program their device to reach better optimization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cardiology and electrophysiology clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults age 18-110 years\n2. Must have a CRT-D (A biventricular pacemaker with defibrillator)\n3. Last optimization of their device (CRT-D) must not have been done in the past 3 months\n4. Must be optimal heart failure medical regimen. This includes target dose of beta-blocker and angiotensin converting enzyme inhibitor (ACE-I) (or equivalent; i.e angiotensin receptor blocker (ARB); or balanced preload and afterload reducers with hydralazine and nitrates.)\n\nExclusion Criteria:\n\n1. Less than 18 years of age or greater than 110 years old.\n2. Does not have a CRT-D\n3. Optimization of their device has occurred in the past 3 months\n4. Not on optimal medical therapy for heart failure as listed in the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT01127334', 'briefTitle': 'Pilot Study Using Echocardiography to Evaluate Patients With Heart Failure and Dyssynchrony Who Have a CRT-D Device', 'organization': {'class': 'OTHER', 'fullName': 'University of Mississippi Medical Center'}, 'officialTitle': 'Validation of a Robust Method for Kinematic Analysis of Ventricular Mechanical Dyssynchrony by Two Dimensional Echocardiography in Patients With Cardiac Resynchronization Devices for Chronic Systolic Heart Failure and Conduction System Disease', 'orgStudyIdInfo': {'id': '2010-0069'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Systolic Heart Failure, Dyssynchrony, CRT-D', 'description': 'Patients with systolic heart failure and dyssynchrony that have a CRT-D that have not been optimized in the past 3 months.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}], 'overallOfficials': [{'name': 'Donny R. Stokes, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Mississippi Medical Center'}, {'name': 'John P. Payne, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Mississippi Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mississippi Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Donny R. Stokes M.D.', 'oldOrganization': 'University of Mississippi Medical Center'}}}}