Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-01-01 @ 1:44 AM
Study NCT ID:
NCT01631006
Status:
COMPLETED
Last Update Posted:
2014-12-19
First Post:
2012-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Continous Positive Airway Pressure (CPAP) in Hypertrophic Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-18', 'studyFirstSubmitDate': '2012-06-26', 'studyFirstSubmitQcDate': '2012-06-27', 'lastUpdatePostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cadiac performance by echocardiography', 'timeFrame': 'acutely'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CPAP', 'Hypertrophic cardiomyopathy', 'Blood Pressure', 'The focus of the present study is to evaluate the acute hemodynamic effects of CPAP in patients with non-obstructive and obstructive hypertrophic cardiomyopathy'], 'conditions': ['Non-obstructive Hypertrophic Cardiomyopathy', 'Obstructive Hypertrophic Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '27167210', 'type': 'DERIVED', 'citation': 'Nerbass FB, Salemi VMC, Pedrosa RP, Portilho NP, Ferreira-Filho JCA, Moriya HT, Antunes MO, Arteaga-Fernandez E, Drager LF, Lorenzi-Filho G. Acute Effects of Nasal CPAP in Patients With Hypertrophic Cardiomyopathy. Chest. 2016 Nov;150(5):1050-1058. doi: 10.1016/j.chest.2016.05.004. Epub 2016 May 7.'}]}, 'descriptionModule': {'briefSummary': 'Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiac disease, is a cause of disability including heart failure, atrial fibrillation, and sudden death, with an annual mortality varying from 1% to 6%. Obstructive sleep apnea (OSA) is extremely common among patients with established cardiovascular disease, including hypertension and atrial fibrillation and when present may contribute to worse cardiovascular outcome. Although patients with HCM do not necessarily have typical characteristics of patients with OSA, such as obesity and increasing age, there is recent evidence that OSA is extremely common among patients with HCM, with a prevalence ranging from 32% to 71%. The presence of OSA among patients with HCM is independently associated with worse structural and functional impairment of the heart, including atrial and aorta enlargement, worse New York Heart Association functional class, and worse quality of life. Therefore, the recognition and treatment of OSA is a new area of research that may impact in the management of patients with HCM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both genders\n* over 18 years-old\n* hemodynamically stable\n* with no other cardiac disease\n* consent form signed\n\nExclusion Criteria:\n\n* presence of pacemaker\n* spontaneous withdrawal\n* previous cardiorespiratory arrest\n* atrial fibrilation during echocardiography'}, 'identificationModule': {'nctId': 'NCT01631006', 'acronym': 'CPAPandHCM', 'briefTitle': 'Effects of Continous Positive Airway Pressure (CPAP) in Hypertrophic Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Acute Hemodynamic Effects of Continous Positive Airway Pressure (CPAP) in Patients With Hypertrophic Cardiomyopathy', 'orgStudyIdInfo': {'id': 'SDC 325209/003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Low CPAP pressure', 'description': 'Patients are submmited to a CPAP with low pressure for 20 minutes', 'interventionNames': ['Device: CPAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High CPAP pressure', 'description': 'Patients are submmited to a high pressure of CPAP for 20 minutes', 'interventionNames': ['Device: CPAP']}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'description': 'A low or high CPAP pressure is delivered for 20 minutes', 'armGroupLabels': ['High CPAP pressure', 'Low CPAP pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Heart Institute', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor of Pulmonary Division', 'investigatorFullName': 'Geraldo Lorenzi-Filho', 'investigatorAffiliation': 'University of Sao Paulo'}}}}