Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-09 @ 4:05 AM
Study NCT ID:
NCT05115994
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-29
First Post:
2021-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antihypertensive and PAP Treatment in Obstructive Sleep Apnea Patients With Hypertension (AHPAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D020521', 'term': 'Stroke'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '14 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2021-11-06', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subanalysis of MCE/death incidence, stratified by blood pressure levels', 'timeFrame': 'First incidence during study, ie within 156 months (13yrs) maximum', 'description': 'Does baseline and end of study BP levels influence our outcomes? Does lower BP targets further reduce the outcome risc?'}], 'primaryOutcomes': [{'measure': 'Major cardiovascular event (MCE) or death', 'timeFrame': 'First incidence during study, ie within 156 months (13 yrs) maximum', 'description': 'First incidence of new myocardial infarction, cardiac failure, stroke or death (cardiovascular and all)'}], 'secondaryOutcomes': [{'measure': 'Blood pressure control', 'timeFrame': 'at study end (latest available BP measurements up to december 2021), ie within 156 months (13 yrs) maximum', 'description': 'According to ESC/EHC 2018 guidelines'}, {'measure': 'New incidence of atrial fibrillation', 'timeFrame': 'First incidence during study, ie within 156 months (13yrs) maximum', 'description': 'New diagnosis from patient registry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Continous positive airway pressure', 'Antihypertensive treatment', 'Risc prevention'], 'conditions': ['Obstructive Sleep Apnea', 'Hypertension', 'Death, Cardiac', 'Treatment Compliance', 'Heart Failure', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '33031170', 'type': 'BACKGROUND', 'citation': 'Svedmyr S, Hedner J, Zou D, Parati G, Ryan S, Hein H, Pepin JL, Tkacova R, Marrone O, Schiza S, Basoglu OK, Grote L; European Sleep Apnea Database (ESADA) study group. Superior hypertension control with betablockade in the European Sleep Apnea Database. J Hypertens. 2021 Feb 1;39(2):292-301. doi: 10.1097/HJH.0000000000002629.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will perform a long term registry based prospective analysis on incidence of major cardiovascular events or death in hypertensive patients with obstructive sleep apnea .\n\nEffects of PAP (positive airway pressure) compliance, antihypertensive medication and blood pressure control will be investigated in the study.', 'detailedDescription': 'By using swedish personal ID numbers the investigators can combine data from several quality registries in Sweden and will start with patients from a primary care registry (QregPV) that had or received a hypertension diagnosis during the period 2008-2012. The investigators will compare those who got an OSA diagnosis in the SESAR (Swedish sleep apnea registry) stratified by high/low PAP compliance with an intraoral device group, a non treated OSA group as well as a control group without OSA until 2021. Main outcome variables will be major cardiovascular events or death. Outcome data will be collected from the National Patient Registry and Cause of death registry.\n\nGroups will be matched by propensity score for known confounders. Secondary analysis will consider modifying effect of different antihypertensive drugs (the Swedish Prescribed Drug Register, type of therapy; DDD comparison) and the actual degree of hypertension control (blood pressure levels) on CV risk. It is intended to stratify the analysis for BP levels in order to evaluate if lower BP targets further reduce CV risk in hypertensive OSA patients. These analyses will likely be reported in separate publications.\n\nHYPOTHESIS\n\n1. PAP treatment in hypertensive OSA patients reduces the long term risk of major cardiovascular events (MCE) and premature death. The risk reduction is modified by PAP compliance, hypertension control and OSA severity.\n2. In hypertensive OSA patients, the investigators previously identified betablockade as a drug class leading to better pressure control (1). The investigators hypothesize that any risk reduction by PAP treated OSA is influenced by the types of antihypertensive drugs used.\n3. Lower blood pressure targets (ie better BP control) may reduce the risk of cardiovascular events in PAP treated OSA patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Propensity score matched registry cohorts', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All hypertensive and obstructive sleep apnea patients present in QregPV and SESAR 2008-2021.\n\nExclusion Criteria:\n\n* Patients in the hypertensive control group (without OSA) will be excluded if they have OSA diagnosis but are not present in the SESAR registry.\n* Subjects with missing data on any of the variables in the fitted model unless the missing data can be accurately imputated.\n* Patients with low life expectancy (Age\\>75 at study start, malignant disease).\n* Patients no longer living in VGR 2021.'}, 'identificationModule': {'nctId': 'NCT05115994', 'acronym': 'AHPAP', 'briefTitle': 'Antihypertensive and PAP Treatment in Obstructive Sleep Apnea Patients With Hypertension (AHPAP)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'Antihypertensive and PAP Treatment in Obstructive Sleep Apnea Patients With Hypertension -Long Term Prospective Analysis on Cardiovascular Events or Death (AHPAP-MCE/Death)', 'orgStudyIdInfo': {'id': 'AHPAP-MCE/death'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypertensive OSA patients, high PAP compliance', 'description': 'Hypertensive OSA patients using their PAP device for at least 4 hrs/night', 'interventionNames': ['Device: Continous positive airway pressure']}, {'label': 'Hypertensive OSA patients, low PAP compliance', 'description': 'Hypertensive OSA patients using their PAP device for less than 4 hrs/night', 'interventionNames': ['Device: Continous positive airway pressure']}, {'label': 'Intra oral device treatment', 'description': 'Hypertensive OSA patients treated with IOD', 'interventionNames': ['Device: Continous positive airway pressure']}, {'label': 'Untreated OSA hypertensive patients', 'description': 'Hypertensive OSA patients not using PAP or IOD'}, {'label': 'Hypertensive patients without OSA', 'description': 'Control population from QregPV without OSA'}], 'interventions': [{'name': 'Continous positive airway pressure', 'type': 'DEVICE', 'otherNames': ['Antihypertensive pharmacological treatment'], 'armGroupLabels': ['Hypertensive OSA patients, high PAP compliance', 'Hypertensive OSA patients, low PAP compliance', 'Intra oral device treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '413 45', 'city': 'Gothenburg', 'state': 'Västra Götaland County', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Sven Svedmyr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vastra Gotalands regionen, Sahlgrenska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, MD Sahlgrenska University Hospital, PhD student Gothenburg University, Specialist internal medicine', 'investigatorFullName': 'Sven Svedmyr', 'investigatorAffiliation': 'Vastra Gotaland Region'}}}}