Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT01100918
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2010-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-12', 'studyFirstSubmitDate': '2010-04-08', 'studyFirstSubmitQcDate': '2010-04-08', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiopulmonary Exercise Testing - changes in Peak VO2 from baseline to 6 months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Change in New York Heart Association (NYHA) class from baseline to 6 months', 'timeFrame': '6 months'}, {'measure': 'Change in Quality-of-Life score from baseline to 6 months', 'timeFrame': '6 months'}, {'measure': 'Echocardiography - changes in left ventricular (LV) volume and dimensions, calculated ejection fractions and in severity of MR', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac resynchronisation therapy', 'Tissue Doppler Imaging', 'Dyssynchrony'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Currently the main selection tool for Cardiac Resynchronisation Therapy (CRT) is the QRS duration on the surface echocardiography (ECG) which has been shown to be a poor predictor of response. We sought to evaluate the use of tissue Doppler (TDI) assessment of dyssynchrony in prediction of response to CRT.\n\nThe hypothesis is that the presence of mechanical dyssynchrony (measured using TDI echocardiography) successfully identifies heart failure patients who will respond to CRT. Conversely, the absence of mechanical dyssynchrony is associated with a low/no response to CRT.\n\nThis is a three arm study. Group 1 comprises patients with dyssynchrony on TDI who are implanted with a biventricular ICD whereas Group 2 patients comprise patients who have no dyssynchrony. Group 2 patients are randomised 1:1 to either receive a biventricular ICD (2a) or an ICD (2b). All patients undergo a NYHA class assessment, a cardiopulmonary exercise test, and an echocardiogram at baseline and at 6 months follow up. Baseline and 6 months findings will be compared in all three groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must have an indication for ICD therapy\n2. Heart failure of any aetiology with evidence of left ventricular (LV) systolic dysfunction with LV ejection fraction \\< 35% and LV cavity dilatation (end diastolic dimension \\> 55 mm)\n3. NYHA Class III/IV symptoms of heart failure despite optimal medical therapy\n4. QRS duration ≥120ms\n\nExclusion Criteria:\n\n1. Reversible cause of heart failure such as ongoing ischaemia amenable to revascularisation or treatable valvular disease\n2. Requirement for ventricular pacing due to atrioventricular block.\n3. Limited life expectancy (\\< 6 months)'}, 'identificationModule': {'nctId': 'NCT01100918', 'acronym': 'TIBI-HF', 'briefTitle': 'Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Barts & The London NHS Trust'}, 'officialTitle': 'Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy in Heart Failure', 'orgStudyIdInfo': {'id': '004844BLT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1: Dyssynchrony positive', 'interventionNames': ['Device: BiV ICD']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2a: Dyssynchrony negative', 'interventionNames': ['Device: BiV ICD']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2b: Dyssynchrony negative', 'interventionNames': ['Device: ICD']}], 'interventions': [{'name': 'BiV ICD', 'type': 'DEVICE', 'description': 'Biventricular ICD', 'armGroupLabels': ['1: Dyssynchrony positive', '2a: Dyssynchrony negative']}, {'name': 'ICD', 'type': 'DEVICE', 'description': 'Implantable Defibrillator', 'armGroupLabels': ['2b: Dyssynchrony negative']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1A 7BE', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Barts and the London NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Richard Schilling, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barts and the London NHS Trust, Queen Mary University of London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}