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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure; Stroke; Hypertension; Obstructive Sleep Apnea; Treatment Compliance; Death, Cardiac
• Intervention / Treatment: Device: Continous positive airway pressure

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• Sweden
  • Västra Götaland
    • Göteborg, Västra Götaland, Sweden, 413 45
      • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Propensity score matched registry cohorts

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypertensive OSA patients, high PAP compliance; Hypertensive OSA patients using their PAP device for at least 4 hrs/night	Device: Continous positive airway pressure; Other Names: Antihypertensive pharmacological treatment
Hypertensive OSA patients, low PAP compliance; Hypertensive OSA patients using their PAP device for less than 4 hrs/night	Device: Continous positive airway pressure; Other Names: Antihypertensive pharmacological treatment
Intra oral device treatment; Hypertensive OSA patients treated with IOD	Device: Continous positive airway pressure; Other Names: Antihypertensive pharmacological treatment
Untreated OSA hypertensive patients; Hypertensive OSA patients not using PAP or IOD
Hypertensive patients without OSA; Control population from QregPV without OSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	New diagnosis from patient registry	First incidence during study, ie within 156 months (13yrs) maximum

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Sven Svedmyr, MD, Vastra Gotalands regionen, Sahlgrenska University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: November 6, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Antihypertensive treatment; Continous positive airway pressure; Risc prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Apnea; Death; Antihypertensive Agents
• Other Study ID Numbers: AHPAP-MCE/death

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No