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OpenTrials
Completed

NCT Number: NCT06930989

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital and Göteborg University

Gothenburg, VGR, 41390, Sweden

About this study

Please see attached analysis plan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive Airway Pressure (PAP)

Device

Intervention as part of routine clinical care. Data from national registries.

Primary outcomes

  1. Major cardiovascular event (MACE)

    Time frame: First event during follow-up 2010-2022

    Major cardiovascular event (MACE) including CV death

  2. Age at first MACE

    Time frame: First event during follow-up 2010-2022

    mean age at first MACE for the groups

  3. All cause death

    Time frame: 2010-2022

    death from any cause during follow-up

Secondary outcomes

  1. Risk reduction with PAP

    Time frame: 2010-2022

    Survival analysis between both OSA groups only stratified by PAP adherence (hours/night)

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Göteborg University
  • Lund University
  • Swedish Heart Lung Foundation
  • Uppsala University

Registry information

Official study title

Twin Threat of OSA and Hypertension on Mortality/CV-risk and Protective Effect by Positive Airway Pressure Treatment.

Acronym: DISCOVERY-HT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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