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Primary Prevention Long-term Registry Study in OSA and Hypertension. Survival Analysis 2010-2022 (DISCOVERY-HT)

V

Vastra Gotaland Region

Status

Completed

Conditions

Hypertension
OSA - Obstructive Sleep Apnea
PAP
Survival Analysis
MACE

Treatments

Device: Positive airway pressure (PAP)

Study type

Observational

Funder types

Other

Identifiers

NCT06930989
SERA Lund DNR:2025-00712-02

Details and patient eligibility

About

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.

Full description

Please see attached analysis plan

Enrollment

148,467 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

148,467 participants in 4 patient groups

Hypertension and obstructive sleep apnea (OSA)
Description:
Patients with hypertension and positive airway pressure (PAP) treated OSA
Treatment:
Device: Positive airway pressure (PAP)
OSA alone
Description:
Patients with PAP teated OSA but no hypertension
Treatment:
Device: Positive airway pressure (PAP)
Hypertension control
Description:
Patients of control population with hypertension
Healthy controls
Description:
Control population without hypertension and without OSA

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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