Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT00828360
Status:
UNKNOWN
Last Update Posted:
2009-01-23
First Post:
2009-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dobutamine Stress Echocardiography in Cardiac Resynchronization Therapy (CRT) Patients Selection
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-22', 'studyFirstSubmitDate': '2009-01-22', 'studyFirstSubmitQcDate': '2009-01-22', 'lastUpdatePostDateStruct': {'date': '2009-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients showing left ventricular reverse remodelling. In particular, a 10% or greater reduction of the left ventricular end-systolic volume (LVESV) is the primary endpoint of the LODO-CRT study.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Clinical composite score, which combines changes in the NYHA class and global assessment with the information provided from the occurrence of major clinical events.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'CRT', 'Dobutamine echocardiography'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '18926147', 'type': 'BACKGROUND', 'citation': 'Muto C, Gasparini M, Iacopino S, Peraldo C, Curnis A, Sassone B, Diotallevi P, Davinelli M, Valsecchi S, Tuccillo B. Efficacy of LOw-dose DObutamine stress-echocardiography to predict cardiac resynchronization therapy response (LODO-CRT) multicenter prospective study: design and rationale. Am Heart J. 2008 Oct;156(4):656-61. doi: 10.1016/j.ahj.2008.06.011. Epub 2008 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'While cardiac resynchronization therapy (CRT) has a well demonstrated therapeutic effect in selected patients with advanced heart failure (HF) on optimized drug therapy, non-responder rate remains high. The low-dose dobutamine stress-echo (DSE) test to predict positive response to CRT (LODO-CRT) trial is designed to improve patient selection for CRT.', 'detailedDescription': 'LODO-CRT is a multicenter prospective study enrolling HF patients with conventional indication to CRT (symptomatic stable NYHA class III-IV on optimized drug therapy, QRS≥120 msec, left ventricular (LV) dilatation, LVEF≤35%) is designed to assess the predictive value of LV contractile reserve (LVCR), determined through DSE, in predicting CRT response during follow-up. Assessment of CRT effects will follow two sequential phases: in phase 1 CRT response end-point is defined as left ventricular end-systolic volume (LVESV) reduction ≥ 10% at 6 months; in phase 2, both LVESV reduction and clinical status via a clinical composite score will be evaluated at 12 months follow-up. Predictive value of LVCR will be compared to other measures, such as LV dyssynchrony measures, through adjusted multivariable analysis. For the purpose of the study, target patient number is 270 patients (with 95% confidence, 80% power, α≤0.05).\n\nLVCR assessment, using low-dose DES test, should effectively predict positive response to CRT both in terms of the reverse remodeling process as well as favorable long-term clinical outcome. Moreover, the predictive value of LVCR will be compared to that of conventional intra-LV dyssynchrony measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient indicated to CRT according to current guidelines', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe HF despite optimized medical therapy\n* NYHA functional class III-IV\n* dilated cardiomyopathy of both ischemic and non-ischemic origin\n* left ventricular ejection fraction (LVEF) \\<=35%\n* QRS complex duration ≥120 ms\n* normal sinus rhythm.\n\nExclusion Criteria:\n\n* younger than 18 years old\n* unstable angina\n* acute myocardial infarction\n* coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months\n* already implanted with a conventional implantable pulse generator or with an implantable cardioverter defibrillator (ICD)\n* previously implanted with a CRT device\n* chronic permanent atrial arrhythmias'}, 'identificationModule': {'nctId': 'NCT00828360', 'acronym': 'LODO-CRT', 'briefTitle': 'Dobutamine Stress Echocardiography in Cardiac Resynchronization Therapy (CRT) Patients Selection', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Santa Maria di Loreto Mare'}, 'officialTitle': 'Efficacy Of Low-Dose Dobutamine Stress-Echocardiography To Predict Cardiac Resynchronization Therapy Response', 'orgStudyIdInfo': {'id': 'LM-001'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bari', 'country': 'Italy', 'facility': 'Anthea Clinic', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Catanzaro', 'country': 'Italy', 'facility': "Sant'Anna Hospital", 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '20100', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '80142', 'city': 'Naples', 'country': 'Italy', 'facility': 'Ospedale Santa Maria di Loreto Mare', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'city': 'Rovigo', 'country': 'Italy', 'facility': 'Santa Maria della Misericordia', 'geoPoint': {'lat': 45.06982, 'lon': 11.79022}}], 'overallOfficials': [{'name': 'Carmine Muto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Santa Maria di Loreto Mare Naples'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Santa Maria di Loreto Mare', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Carmine Muto', 'oldOrganization': 'Ospedale Santa Maria di Loreto Mare Napoli'}}}}