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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 .
Effects of PAP (positive airway pressure) compliance, antihypertensive medication and blood pressure control will be investigated in the study.
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.
Groups 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.
HYPOTHESIS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertensive OSA patients, high PAP compliance | Hypertensive OSA patients using their PAP device for at least 4 hrs/night |
| |
| Hypertensive OSA patients, low PAP compliance | Hypertensive OSA patients using their PAP device for less than 4 hrs/night |
| |
| Intra oral device treatment | Hypertensive OSA patients treated with IOD |
| |
| Untreated OSA hypertensive patients | Hypertensive OSA patients not using PAP or IOD | ||
| Hypertensive patients without OSA | Control population from QregPV without OSA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continous positive airway pressure | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major cardiovascular event (MCE) or death | First incidence of new myocardial infarction, cardiac failure, stroke or death (cardiovascular and all) | First incidence during study, ie within 156 months (13 yrs) maximum |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure control | According to ESC/EHC 2018 guidelines | at study end (latest available BP measurements up to december 2021), ie within 156 months (13 yrs) maximum |
| New incidence of atrial fibrillation |
| Measure | Description | Time Frame |
|---|---|---|
| Subanalysis of MCE/death incidence, stratified by blood pressure levels | Does baseline and end of study BP levels influence our outcomes? Does lower BP targets further reduce the outcome risc? | First incidence during study, ie within 156 months (13yrs) maximum |
Inclusion Criteria:
Exclusion Criteria:
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Propensity score matched registry cohorts
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| Name | Affiliation | Role |
|---|---|---|
| Sven Svedmyr, MD | Vastra Gotalands regionen, Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | Västra Götaland County | 413 45 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33031170 | Background | 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. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D006973 | Hypertension |
| D003643 | Death |
| D010349 | Patient Compliance |
| D006333 | Heart Failure |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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New diagnosis from patient registry
| First incidence during study, ie within 156 months (13yrs) maximum |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D006331 | Heart Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |