Antihypertensive and PAP Treatment in Obstructive Sleep Apnea Patients With Hypertension -Long Term Prospective Analysis on Cardiovascular Events or Death (AHPAP-MCE/Death)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Major cardiovascular event (MCE) or death
研究概览
简要总结
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.
详细描述
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
- 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.
- 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.
- Lower blood pressure targets (ie better BP control) may reduce the risk of cardiovascular events in PAP treated OSA patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All hypertensive and obstructive sleep apnea patients present in QregPV and SESAR 2008-2021.
排除标准
- •Patients in the hypertensive control group (without OSA) will be excluded if they have OSA diagnosis but are not present in the SESAR registry.
- •Subjects with missing data on any of the variables in the fitted model unless the missing data can be accurately imputated.
- •Patients with low life expectancy (Age>75 at study start, malignant disease).
- •Patients no longer living in VGR 2021.
结局指标
主要结局
Major cardiovascular event (MCE) or death
时间窗: 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)
次要结局
- Blood pressure control(at study end (latest available BP measurements up to december 2021), ie within 156 months (13 yrs) maximum)
- New incidence of atrial fibrillation(First incidence during study, ie within 156 months (13yrs) maximum)
研究者
Sven Svedmyr
Principal investigator, MD Sahlgrenska University Hospital, PhD student Gothenburg University, Specialist internal medicine
Vastra Gotaland Region