Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 413 45, Sweden
NCT Number: NCT05115994
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–75 year
All sexes
Observational
Gothenburg, Västra Götaland County, 413 45, Sweden
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Antihypertensive pharmacological treatment
Time frame: First incidence during study, ie within 156 months (13 yrs) maximum
First incidence of new myocardial infarction, cardiac failure, stroke or death (cardiovascular and all)
Time frame: at study end (latest available BP measurements up to december 2021), ie within 156 months (13 yrs) maximum
According to ESC/EHC 2018 guidelines
Time frame: First incidence during study, ie within 156 months (13yrs) maximum
New diagnosis from patient registry
Time frame: First incidence during study, ie within 156 months (13yrs) maximum
Does baseline and end of study BP levels influence our outcomes? Does lower BP targets further reduce the outcome risc?
Vastra Gotaland Region
Other Gov
Antihypertensive and PAP Treatment in Obstructive Sleep Apnea Patients With Hypertension -Long Term Prospective Analysis on Cardiovascular Events or Death (AHPAP-MCE/Death)
Acronym: AHPAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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