Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-05 @ 6:02 PM
Study NCT ID:
NCT03936751
Status:
TERMINATED
Last Update Posted:
2024-06-07
First Post:
2019-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: CPAP-CARE STUDY.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'whyStopped': 'COVID-19 pandemic and philips cpap machine recall', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2019-04-05', 'studyFirstSubmitQcDate': '2019-04-30', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of ACPE recurrence', 'timeFrame': '1-year', 'description': 'To evaluate the effects of CPAP on the recurrence of ACPE as compared to placebo'}], 'secondaryOutcomes': [{'measure': 'Rate of all-cause mortality', 'timeFrame': '1-year', 'description': 'To evaluate the effects of CPAP on the all-cause mortality as compared to placebo'}, {'measure': 'Rate of cardiovascular mortality', 'timeFrame': '1-year', 'description': 'To evaluate the effects of CPAP on the cardiovascular mortality as compared to placebo'}, {'measure': 'Number of new hospital admissions', 'timeFrame': '1-year', 'description': 'To evaluate the effects of CPAP on the number of new hospital admissions as compared to placebo'}, {'measure': 'Blood pressure effects ( (mmHg)', 'timeFrame': '1-year', 'description': 'To evaluate the effects of CPAP on the blood pressure reduction as compared to placebo'}, {'measure': 'Levels of BNP levels (pg/ml)', 'timeFrame': '1-year', 'description': 'To evaluate the effects of CPAP on the BNP levels as compared to placebo'}, {'measure': 'Cardiac function (left ventricular ejection fraction - %)', 'timeFrame': '1-year', 'description': 'To evaluate the effects of CPAP on the left ventricular ejection fraction (by echocardiography) as compared to placebo'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea', 'Pulmonary Edema Cardiac Cause']}, 'descriptionModule': {'briefSummary': 'Despite the advances in the treatment of acute cardiogenic pulmonary edema (ACPE), the readmissions rates and cardiovascular events remain very high. In this context, it is possible that other potential risk factors may influence the poor prognosis of the ACPE. One of these potential candidates is Obstructive Sleep Apnea(OSA). This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with ACPE. The primary outcome will be to evaluate the impact of CPAP on the recurrence of ACPE in the 1-year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertensive acute Cardiogenic Pulmonary Edema\n* Moderate to Severe OSA\n\nExclusion Criteria:\n\n* Professional drivers\n* Pregnancy\n* Non-Cardiogenic Pulmonary edema\n* Terminal cancer'}, 'identificationModule': {'nctId': 'NCT03936751', 'acronym': 'CPAP-CARE', 'briefTitle': 'Obstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: CPAP-CARE STUDY.', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Impact of Obstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: a Multicenter Randomized Controlled Study (CPAP-CARE STUDY).', 'orgStudyIdInfo': {'id': 'SDC 4782/18/148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CPAP', 'description': 'Continuous positive airway pressure', 'interventionNames': ['Device: CPAP']}, {'type': 'SHAM_COMPARATOR', 'label': 'Nasal strips', 'description': 'Nasal Strips', 'interventionNames': ['Device: Nasal Strips']}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'description': 'This is the standard treatment for OSA.', 'armGroupLabels': ['CPAP']}, {'name': 'Nasal Strips', 'type': 'DEVICE', 'description': 'Nasal strips were commercially available in the market for supposing treat snoring and sleep apnea but no proof that this is true. Our group previously validated nasal strips as an interesting placebo.', 'armGroupLabels': ['Nasal strips']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Recife', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'PROCAPE - University of Pernambuco'}, {'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Samaritano', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05049000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Heart Institute (InCor)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Dante Pazzanese', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Respironics', 'class': 'INDUSTRY'}, {'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}, {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Luciano F Drager, MD, PhD', 'investigatorAffiliation': 'University of Sao Paulo'}}}}