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NCT Number: NCT05115994

Antihypertensive and PAP Treatment in Obstructive Sleep Apnea Patients With Hypertension (AHPAP)

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.

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This study is active but is not currently recruiting participants.

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Key information

About this 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

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All hypertensive and obstructive sleep apnea patients present in QregPV and SESAR 2008-2021.

Exclusion criteria

  • 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.

Treatment and study plan

Continous Positive Airway Pressure

Device

Other names: Antihypertensive pharmacological treatment

Primary outcomes

  1. Major cardiovascular event (MCE) or death

    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)

Secondary outcomes

  1. Blood pressure control

    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

  2. New incidence of atrial fibrillation

    Time frame: First incidence during study, ie within 156 months (13yrs) maximum

    New diagnosis from patient registry

Other outcomes

  1. Subanalysis of MCE/death incidence, stratified by blood pressure levels

    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?

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2021
Registry last updated
Dec 30, 2025

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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