Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-02-22 @ 7:26 AM
Study NCT ID:
NCT02073305
Status:
UNKNOWN
Last Update Posted:
2020-03-04
First Post:
2014-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '7 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2014-02-25', 'studyFirstSubmitQcDate': '2014-02-25', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first major cardiovascular event', 'timeFrame': '3 years', 'description': 'composite end-point of all-cause mortality, acute myocardial infarction, hospitalization for acute myocardial ischemia, acute heart failure, stroke, acute peripheral vascular event'}], 'secondaryOutcomes': [{'measure': 'Time to cardiovascular death', 'timeFrame': '3 years'}, {'measure': 'Time to first non-fatal acute myocardial infarction', 'timeFrame': '3 years'}, {'measure': 'Time to first hospitalization for acute myocardial ischemia', 'timeFrame': '3 years'}, {'measure': 'Time to first acute heart failure', 'timeFrame': '3 years'}, {'measure': 'Time to first non-fatal stroke', 'timeFrame': '3 years'}, {'measure': 'Time to first acute peripheral vascular event', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obstructive sleep apnea', 'end stage renal disease', 'cardiovascular events'], 'conditions': ['Obstructive Sleep Apnea', 'End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prospectively evaluate the impact of sleep apnea on the cardiovascular morbidity and mortality of patients with end-stage renal disease.', 'detailedDescription': 'Sleep apnea is more prevalent in end stage renal disease patients than in the general population, and may participate to the increased cardiovascular mortality observed in this group of patients. Despite a significant increase in knowledge about the harmful effects of obstructive sleep apnea in the general population, the prognostic impact of sleep apnea in the end stage renal disease population has not yet been investigated.\n\nThe purpose of this trial is to investigate the hypothesis that moderate to severe sleep apnea increase the risk of major cardiovascular events in patients with end stage renal disease.\n\nThe severity of sleep apnea is measured at inclusion and the patients are followed during 3 years to assess the cardiovascular end-points. The result of the sleep study is communicated to the treating physician and the decision whether to treat or not sleep apnea is left to the treating physician, independently of the study protocol. The comparison will include three groups: patients without sleep apnea, untreated patients with moderate to severe sleep apnea and treated patients with sleep apnea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with end stage renal disease on renal replacement therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* end stage renal disease on renal replacement therapy\n* age ≥ 18 years\n\nExclusion Criteria:\n\n* unstable congestive heart failure\n* active psychiatric disease'}, 'identificationModule': {'nctId': 'NCT02073305', 'acronym': 'SASinHD_003', 'briefTitle': 'Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients', 'orgStudyIdInfo': {'id': 'CIRS-SASinHD_003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No sleep apnea', 'description': 'Subjects with no or light sleep apnea (AHI \\< 15/h)', 'interventionNames': ['Other: No Sleep Apnea']}, {'label': 'Sleep Apnea - untreated', 'description': 'Subjects with moderate to severe sleep apnea (AHI ≥15/h) and no specific treatment.\n\nDecision to treat or not sleep apnea is left to the treating physician, independently of the study protocol.', 'interventionNames': ['Other: Sleep Apnea - untreated']}, {'label': 'Sleep Apnea - treated', 'description': 'Subjects with treated moderate to severe sleep apnea (AHI ≥15/h). Decision to treat or not sleep apnea is left to the treating physician, independently of the study protocol.', 'interventionNames': ['Device: Sleep Apnea - treated']}], 'interventions': [{'name': 'No Sleep Apnea', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['No sleep apnea']}, {'name': 'Sleep Apnea - untreated', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Sleep Apnea - untreated']}, {'name': 'Sleep Apnea - treated', 'type': 'DEVICE', 'description': 'Sleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance', 'armGroupLabels': ['Sleep Apnea - treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': "Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)", 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Raphaël Heinzer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)"}, {'name': 'Adam Ogna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)"}, {'name': 'Valentina Forni Ogna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Centre d'Investigation et Recherche sur le Sommeil (CIRS)", 'investigatorFullName': 'Adam Ogna', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}