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

Stroke Clinical Trial

— AHPAP  

Official title:

Antihypertensive and PAP Treatment in Obstructive Sleep Apnea Patients With Hypertension -Long Term Prospective Analysis on Cardiovascular Events or Death (AHPAP-MCE/Death)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05115994
• Other study ID #: AHPAP-MCE/death
• Status: Active, not recruiting
• Start date: January 2008
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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 1. 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. 2. 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. 3. Lower blood pressure targets (ie better BP control) may reduce the risk of cardiovascular events in PAP treated OSA patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Death
• Death, Cardiac
• Heart Failure
• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke
• Treatment Compliance

Intervention

Device:
• Continous positive airway pressure

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg	Västra Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Svedmyr S, Hedner J, Zou D, Parati G, Ryan S, Hein H, Pepin JL, Tkácová 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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
Secondary	New incidence of atrial fibrillation	New diagnosis from patient registry	First incidence during study, ie within 156 months (13yrs) maximum