Clinical trial NCT06930989: Primary Prevention Long-term Registry Study in OSA and Hypertension. Survival Analysis 2010-2022
Official title: Twin Threat of OSA and Hypertension on Mortality/CV-risk and Protective Effect by Positive Airway Pressure Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
OSA - Obstructive Sleep Apnea
MACE
Survival Analysis
PAP
Keywords: Primary CV prevention
hypertension
OSA
PAP
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Swedish Heart Lung Foundation
name: Göteborg University
name: Lund University
name: Uppsala University
First posted: 2025-04-16
Enrollment: 148467
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Discovery ("Course of DISease in patients reported to the Swedish CPAP Oxygen and VEntilator RegistrY") 2.0 is a large clinical cohort on patients with home mechanical ventilation, long-term oxygen treatment and/or CPAP treatment with data from the Swedish national register for patients on Long Term Oxygen Therapy and Home Mechanical Ventilation (Swedevox) and the Swedish Sleep Apnea Registry (SESAR). Data are cross referenced using Swedish personal IDs with data from multiple Swedish national registries including the National Patients diagnosis registry, National prescription registry, National Cause of Death Register, and SCBs registries on socioeconomic information. All patients starting PAP treatment for OSA during 2010-2021 are included.

Brief summary: Hypertension and obstructive sleep apnea (OSA) are both common conditions that independently increase the risk cardiovascular disease including atrial fibrillation, ischemic heart disease, heart failure and stroke. OSA is also an independent promoter of hypertension development and poorly controlled hypertension is overrepresented in OSA. Finally, HT and OSA share many risk factors including obesity, and several lifestyle factors. Altogether, these links contribute to a high prevalence of patients with both disorders.

The investigators suspect participants with HT and OSA are at even higher CV risk and may get their first CV event earlier in life. Comparison between HT and OSA participants vs HT alone, OSA alone or healthy controls has not previously been investigated in large studies.

Thus, the investigators aim to investigate long-term risk of major cardiovascular events (MACE) or death comparing these groups in registry data between 2010-2022 in Sweden. The investigators will also investigate the protecting effect of positive airway pressure (PAP) on the OSA related CV risk increase and how many hours/night of PAP use is needed to get any protective effects.

Detailed description: Please see attached analysis plan

Eligibility criteria: Inclusion Criteria:

* Adult patients starting PAP treatment for OSA in the swedevox registry between 2010-2021 with and without hypertension. Randomly selected controls with and without hypertension from the general population.

Exclusion Criteria:

* Patients with manifest cardiovascular disease (stroke, ischemic heart disease, cardiac failure or atrial fibrillation at baseline).
* Patients with kidney failure at baseline.
* Patients with malignant cancer at baseline.
* Subjects with missing data on any of the main variables in the fitted models.

Primary outcomes:
measure: Major cardiovascular event (MACE)
timeFrame: First event during follow-up 2010-2022
measure: Age at first MACE
timeFrame: First event during follow-up 2010-2022
measure: All cause death
timeFrame: 2010-2022
Secondary outcomes:
measure: Risk reduction with PAP
timeFrame: 2010-2022
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital and Göteborg University
state: VGR
Study officials:
affiliation: Sahlgrenska University Hospital
name: Sven Svedmyr, MD
role: PRINCIPAL_INVESTIGATOR
References: