Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-25 @ 10:03 PM
Study NCT ID:
NCT02986633
Status:
RECRUITING
Last Update Posted:
2018-07-19
First Post:
2016-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Echocardiography in Cardiac Resynchronization Therapy (Echo-CRT)
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': 1000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-18', 'studyFirstSubmitDate': '2016-12-05', 'studyFirstSubmitQcDate': '2016-12-06', 'lastUpdatePostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in left ventricular end-systolic volume measured by echocardiography', 'timeFrame': '9 months after implantation'}], 'secondaryOutcomes': [{'measure': 'Death rate', 'timeFrame': '2, 4, 6, 8 and 10 years after implantation'}, {'measure': 're-hospitalisation rate', 'timeFrame': '2, 4, 6, 8 and 10 years after implantation'}, {'measure': 'Changes in left ventricular ejection fraction measured by echocardiography', 'timeFrame': '9 months after implantation'}, {'measure': 'Changes in left ventricular end-diastolic volume measured by echocardiography', 'timeFrame': '9 months after implantation'}, {'measure': 'Changes in left ventricular longitudinal strain measured by echocardiography', 'timeFrame': '9 months after implantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac Resynchronization Therapy', 'Echocardiography', 'Biventricular Pacing'], 'conditions': ['Heart Failure', 'Cardiac Resynchronization Therapy']}, 'referencesModule': {'references': [{'pmid': '37038875', 'type': 'DERIVED', 'citation': 'Layec J, Decroocq M, Delelis F, Appert L, Guyomar Y, Riolet C, Dumortier H, Mailliet A, Tribouilloy C, Marechaux S, Menet A. Dyssynchrony and Response to Cardiac Resynchronization Therapy in Heart Failure Patients With Unfavorable Electrical Characteristics. JACC Cardiovasc Imaging. 2023 Jul;16(7):873-884. doi: 10.1016/j.jcmg.2022.12.023. Epub 2023 Mar 8.'}, {'pmid': '30595180', 'type': 'DERIVED', 'citation': 'Appert L, Menet A, Altes A, Ennezat PV, Bardet-Bouchery H, Binda C, Guyomar Y, Delelis F, Castel AL, Le Goffic C, Guerbaai RA, Graux P, Tribouilloy C, Marechaux S. Clinical Significance of Electromechanical Dyssynchrony and QRS Narrowing in Patients With Heart Failure Receiving Cardiac Resynchronization Therapy. Can J Cardiol. 2019 Jan;35(1):27-34. doi: 10.1016/j.cjca.2018.10.019. Epub 2018 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'The present observational prospective study aims at identifying echocardiographic parameters (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV) ascertained using new methods of echocardiography including speckle tracking strain) that are linked to Cardiac Resynchronization Therapy (CRT) response and a better outcome following CRT', 'detailedDescription': 'The Cardiac Resynchronization Therapy (CRT) reduces mortality of patients with heart failure and reduced LV ejection fraction. The clinical benefit of CRT is mediated by LV reverse remodelling (decrease in LV end-systolic volume over time). However, 30 to 50 % of these patients will not experience LV reverse remodelling following CRT.\n\nClassical parameters of dyssynchrony obtained by conventional methods of echocardiography (including doppler tissue imaging) have a limited value in predicting CRT response. Meanwhile, patients with a Left Bundle Branch Block (LBBB) on the electrocardiogram experience more frequently LV reverse remodelling than those without a LBBB.\n\nLBBB is responsible for specific LV contractile abnormalities that can be identified by speckle tracking strain echocardiography (early septal contraction, stretching of late contraction of the postero-lateral wall). The predictive value of these abnormalities remains to be studied.\n\nThus, it has been hypothesised that these LBBB-related contractile abnormalities may be independent predictors of LV reverse remodelling and outcome following CRT.\n\nThe present observational prospective study aims at identifying echocardiographic parameters (based on the LBBB-like contraction of the LV ascertained using new methods of echocardiography including speckle tracking strain) that are linked to CRT response and a better outcome following CRT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with LV systolic dysfunction and QRS duration \\> 120 ms receiving CRT at GHICL.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heart failure with left ventricular ejection fraction less than 35 %\n* QRS duration over than 120 ms\n* Clinical indication for CRT\n\nExclusion Criteria:\n\n* Rythmologic indication of CRT for atrial fibrillation control\n* Rythmologic indication of CRT for left ventricular ejection fraction between 35% and 45%'}, 'identificationModule': {'nctId': 'NCT02986633', 'acronym': 'Echo-CRT', 'briefTitle': 'Echocardiography in Cardiac Resynchronization Therapy (Echo-CRT)', 'organization': {'class': 'OTHER', 'fullName': 'Lille Catholic University'}, 'officialTitle': 'Prediction of Response to Cardiac Resynchronization Therapy by New Echocardiographic Methods', 'orgStudyIdInfo': {'id': 'OBS-009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with heart failure and CRT', 'description': 'Heart failure with left ventricular ejection fraction less than 35 % treated with CRT', 'interventionNames': ['Other: Echocardiography']}], 'interventions': [{'name': 'Echocardiography', 'type': 'OTHER', 'armGroupLabels': ['Patients with heart failure and CRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59462', 'city': 'Lomme', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amélie Lansiaux, MD, PhD', 'role': 'CONTACT', 'email': 'lansiaux.amelie@ghicl.net', 'phone': '00 33 3 20 52 69'}], 'facility': 'Hospitals of Lille Catholic University (GHICL)', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}], 'centralContacts': [{'name': 'Amélie Lansiaux, MD, PhD', 'role': 'CONTACT', 'email': 'lansiaux.amelie@ghicl.net', 'phone': '00 33 3 20 52 69'}], 'overallOfficials': [{'name': 'Sylvestre Maréchaux, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital of Lille Catholic University (GHICL)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lille Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}