Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-01-01 @ 2:30 AM
Study NCT ID:
NCT00901212
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2009-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Resynchronization Therapy for Heart Failure (EARTH)
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-06', 'studyFirstSubmitDate': '2009-05-12', 'studyFirstSubmitQcDate': '2009-05-12', 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is total exercise duration at a constant submaximal load (ETT submaximal load is defined as 75% of peak exercise during the baseline metabolic evaluation)', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Clinical, electrical, echocardiographic, MUGA scan endpoints, Neuro-hormones', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'resynchronisation', 'ICD'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '34953062', 'type': 'DERIVED', 'citation': "Legris V, Thibault B, Dupuis J, White M, Asgar AW, Fortier A, Pitre C, Bouabdallaoui N, Henri C, O'Meara E, Ducharme A; EARTH Investigators. Right ventricular function and its coupling to pulmonary circulation predicts exercise tolerance in systolic heart failure. ESC Heart Fail. 2022 Feb;9(1):450-464. doi: 10.1002/ehf2.13726. Epub 2021 Dec 24."}, {'pmid': '22104549', 'type': 'DERIVED', 'citation': "Thibault B, Ducharme A, Harel F, White M, O'Meara E, Guertin MC, Lavoie J, Frasure-Smith N, Dubuc M, Guerra P, Macle L, Rivard L, Roy D, Talajic M, Khairy P; Evaluation of Resynchronization Therapy for Heart Failure (GREATER-EARTH) Investigators. Left ventricular versus simultaneous biventricular pacing in patients with heart failure and a QRS complex >/=120 milliseconds. Circulation. 2011 Dec 20;124(25):2874-81. doi: 10.1161/CIRCULATIONAHA.111.032904. Epub 2011 Nov 21."}, {'pmid': '21791363', 'type': 'DERIVED', 'citation': 'Thibault B, Harel F, Ducharme A, White M, Frasure-Smith N, Roy D, Philippon F, Dorian P, Talajic M, Dubuc M, Gagne P, Guerra PG, Macle L, Rivard L, Khairy P. Evaluation of resynchronization therapy for heart failure in patients with a QRS duration greater than 120 ms (GREATER-EARTH) trial: rationale, design, and baseline characteristics. Can J Cardiol. 2011 Nov-Dec;27(6):779-86. doi: 10.1016/j.cjca.2011.03.010. Epub 2011 Jul 24.'}]}, 'descriptionModule': {'briefSummary': 'Heart failure is a major health problem in Canada. Recent advances in medical and device therapy have helped to reduce the morbidity and mortality of patients with this problem. Among these treatments, cardiac resynchronization therapy (CRT) has very recently been shown to be effective to improve functional class, quality of life and exercise tolerance of the patients with the most severe symptoms of heart failure and a prolonged duration of the QRS on the 12-lead Electrocardiography (ECG).', 'detailedDescription': 'Resynchronization of the failing ventricle is currently achieved by pacing the left and right ventricles simultaneously with specialized electrodes and a cardiac stimulator. However, controversy persists concerning the optimal configuration for cardiac pacing in these patients. Right ventricular pacing alone has been shown to be deleterious in some patient populations. The benefits of biventricular pacing in heart failure patients may be due primarily to left ventricular stimulation and may, in some patients, be decreased by the presence of simultaneous RV stimulation. Preliminary data from our own animal work suggest that in the majority of cases, LV stimulation alone is better than RV stimulation, and that BiV stimulation represents an intermediary situation between LV and RV stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (for Greater and Lesser EARTH):\n\nPatient must answer "yes"\n\n1. Does the patient require an ICD or an ICD replacement?\n2. Does the patient have a documented LVEF less than or equal to 35% measured in the previous 6 months (without major concomitant clinical event)?\n3. Does the patient have a QRS duration \\< 120 ms?\n4. Is the patient in sinus rhythm?\n5. Was the six-minute walk test distance less than 400 meters and limited by heart failure symptoms?\n\nExclusion Criteria:\n\nPatient must have answered "NO" to all of the exclusion criteria\n\n1. Does the patient have:\n\n * Indication for permanent ventricular pacing?\n * Chronotropic insufficiency?\n * Second or third degree AV block, either persistent or intermittent?\n * A pacemaker or an ICD which is paced in ventricular chamber more than 5% of the time?\n2. Does the patient have a reversible cause of LV dysfunction such as post-partum cardiomyopathy, tachycardia induced cardiomyopathy, acute myocarditis or acute toxic cardiomyopathy (including acute alcoholic)?\n3. Did the patient have myocardial infarction or cardiac surgery in the 6 weeks preceding the pre-implant visit?\n4. Does the patient have a moderate or severe cardiac valve stenosis?\n5. Is the patient\'s capacity to walk is limited by reasons other than heart failure symptoms (e.g., angina, intermittent claudication, severe lung condition or arthritis)?\n6. Does the patient have severe coexisting illnesses making survival \\> 6 months unlikely?\n7. Is the patient pregnant and/or nursing?\n8. Is the patient unable or unwilling to consent or to comply with follow-up requirements?\n9. Is the patient participating in another clinical study potentially interfering with the present trial?\n10. Does the patient have a resynchronization system in place?'}, 'identificationModule': {'nctId': 'NCT00901212', 'acronym': 'EARTH', 'briefTitle': 'Evaluation of Resynchronization Therapy for Heart Failure (EARTH)', 'organization': {'class': 'OTHER', 'fullName': 'Montreal Heart Institute'}, 'officialTitle': 'Evaluation fo Resynchronization Therapy for Heart Failure (EARTH)', 'orgStudyIdInfo': {'id': 'UCT-67914 (Greater Earth)'}, 'secondaryIdInfos': [{'id': '42560370'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LV Pacing', 'description': 'left univentricular pacing', 'interventionNames': ['Device: Device programming']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BV Pacing', 'description': 'biventricular pacing', 'interventionNames': ['Device: Device programming']}], 'interventions': [{'name': 'Device programming', 'type': 'DEVICE', 'description': '6-month period', 'armGroupLabels': ['BV Pacing', 'LV Pacing']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St-Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'QEII Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Sunnybrook & Women's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St-Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J1H 5N4', 'city': 'Fleurimont', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUS-Fleurimont', 'geoPoint': {'lat': 45.40842, 'lon': -71.83796}}, {'zip': 'H1T1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1T8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM-Hôpital Hotel-Dieu', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Sacre-Coeur Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut Univ de Cardiologie et de Pneumologie de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Bernard MD, Thibault', 'role': 'STUDY_CHAIR', 'affiliation': 'Montreal Heart Institute Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montreal Heart Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Bernard Thibault', 'investigatorAffiliation': 'Montreal Heart Institute'}}}}