Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 1:00 AM
Study NCT ID:
NCT05115994
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-29
First Post:
2021-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antihypertensive and PAP Treatment in Obstructive Sleep Apnea Patients With Hypertension (AHPAP)
Sponsor:
Vastra Gotaland Region
Organization:
Study Overview
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)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AHPAP
Brief 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.
Effects of PAP (positive airway pressure) compliance, antihypertensive medication and blood pressure control will be investigated in the study.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: