Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-01-04 @ 10:11 AM
Study NCT ID:
NCT00812695
Status:
COMPLETED
Last Update Posted:
2011-11-23
First Post:
2008-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Continuous Positive Airway Pressure (CPAP) in Patients With Resistant Hypertension and Obstructive Sleep Apnea (OSA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D006973', 'term': 'Hypertension'}], '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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-21', 'studyFirstSubmitDate': '2008-12-19', 'studyFirstSubmitQcDate': '2008-12-19', 'lastUpdatePostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ambulatory blood pressure monitoring', 'timeFrame': 'Change from Baseline in Blood Pressure at 6 months'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Arterial stiffness at 6 months', 'timeFrame': 'baseline and 6 months'}, {'measure': 'change from baseline in heart remodeling at 6 months', 'timeFrame': 'baseline and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obstructive sleep apnea', 'Refractory hypertension', 'Heart remodeling', 'Arterial stiffness', 'CPAP'], 'conditions': ['Obstructive Sleep Apnea', 'Refractory Hypertension']}, 'referencesModule': {'references': [{'pmid': '23598607', 'type': 'DERIVED', 'citation': 'Pedrosa RP, Drager LF, de Paula LKG, Amaro ACS, Bortolotto LA, Lorenzi-Filho G. Effects of OSA treatment on BP in patients with resistant hypertension: a randomized trial. Chest. 2013 Nov;144(5):1487-1494. doi: 10.1378/chest.13-0085.'}]}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea (OSA) is an important cause of refractory hypertension but the impact of treatment with continuous positive airway pressure (CPAP) is not completely understood. The aim of this project is to study the effects of CPAP on blood pressure control and its influences on cardiac remodeling and arterial stiffness in patients with refractory hypertension and moderate or severe OSA.', 'detailedDescription': 'Study design Interventional, open-label, randomized.\n\nPatients selection\n\nFifty refractory hypertensive patients with moderate-to-severe OSA, aged between 30 to 65 years old will be recruited from the outpatient clinics of the Heart Institute by the hospital staff.\n\nRefractory hypertension will be defined as usually: blood pressure higher than or equal to 140x90 mmHg after a regimen of three drugs, including a diuretic for a minimum of 3 months. Initial evaluation will consist on ambulatory blood pressure measurement for 24 hours and a detailed clinical examination. Moderate to severe OSA will be defined as an apnea-hypopnea index \\> 15 evens per hour, after an overnight polysomnography.\n\nExclusion criteria include BMI \\>40 kg/m2; diabetes mellitus; aortic, heart and valve diseases; renal failure; other identifiable causes of hypertension, no adherence, use of cocaine, amphetamines, other illicit drugs, sympathomimetics (decongestants, anorectics), oral contraceptive hormones, nonsteroidal anti-inflammatory drugs.\n\nRefractory hypertension Secondary causes of hypertension will be excluded using usual procedures from the Hypertension Unit.\n\nPolysomnography All participants will be submitted to standard overnight polysomnography (EMBLA - Flagra hf. Medical Devices, Reykjavik, Iceland). The apnea-hypopnea index will be calculated as the total number of respiratory events (apneas plus hypopneas) per hour of sleep.\n\nApnea will be defined as an air flow cessation greater than 10 seconds and hypopnea as a reduction grater than 50% with oxygen saturation fall grater than 4% or arousal.\n\nAfter recruitment, patients will be instructed about CPAP working by an experimented professional and another polysomnography will be done to adjust pressures. Hour counter will be used to check the adherence to CPAP.\n\nIntervention Patients will be divided in two groups: medical treatment plus CPAP or medical treatment alone for 6 months without drug dose changing.\n\nTwenty-four hour blood pressure monitoring Twenty-four hour blood pressure monitoring (system SpaceLabs 90207) will be used in all patients in the beginning and at the end of the study.\n\nArterial Stiffness Carotid-femoral arterial stiffness will be determined by Complior.\n\nEchocardiography Echocardiography will be performed by using a commercially available machine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refractory hypertensive patients with moderate-to-severe OSA, aged between 30 to 65 years old.\n\nExclusion Criteria:\n\n* Aortic, heart and valve diseases\n* Renal failure\n* Other identifiable causes of hypertension, no adherence, use of cocaine, amphetamines, other illicit drugs, sympathomimetics (decongestants, anorectics), oral contraceptive hormones, nonsteroidal anti-inflammatory drugs.'}, 'identificationModule': {'nctId': 'NCT00812695', 'briefTitle': 'Effects of Continuous Positive Airway Pressure (CPAP) in Patients With Resistant Hypertension and Obstructive Sleep Apnea (OSA)', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effects of Continuous Positive Airway Pressure in Patients With Resistant Hypertension and Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'RH-OSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1'}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'CPAP', 'interventionNames': ['Device: CPAP']}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'description': 'Gold standard treatment for Obstructive sleep apnea', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-904', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Heart Institute (InCor)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD; PhD', 'investigatorFullName': 'Geraldo Lorenzi-Filho', 'investigatorAffiliation': 'University of Sao Paulo'}}}}