HypertensionDISCOVERY-HTNCT06930989
Primary Prevention Long-term Registry Study in OSA and Hypertension. Survival Analysis 2010-2022
An observational study of Hypertension and OSA - Obstructive Sleep Apnea, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, OSA - Obstructive Sleep Apnea, MACE
- What is being tested?
- Positive airway pressure (PAP)
- Type of treatment
- Medical device
- How many people
- 148,467 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2025to 30 Apr 2025
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital and Göteborg University
Gothenburg, VGR, 41390
About this study
Official title: Twin Threat of OSA and Hypertension on Mortality/CV-risk and Protective Effect by Positive Airway Pressure Treatment.
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.
Read the detailed description
Please see attached analysis plan
- Conditions
- Hypertension, OSA - Obstructive Sleep Apnea, MACE, Survival Analysis, PAP
- Being tested
- Positive airway pressure (PAP)
- Keywords
- Primary CV prevention, hypertension, OSA, PAP
- Medical subject headings
- Hypertension, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive airway pressure (PAP)Device
Intervention as part of routine clinical care. Data from national registries.
| Study group | Role | What they receive |
|---|---|---|
| Hypertension and obstructive sleep apnea (OSA) | Patients with hypertension and positive airway pressure (PAP) treated OSA Receives: Device: Positive airway pressure (PAP) | |
| OSA alone | Patients with PAP teated OSA but no hypertension Receives: Device: Positive airway pressure (PAP) | |
| Hypertension control | Patients of control population with hypertension | |
| Healthy controls | Control population without hypertension and without OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiovascular event (MACE)
Major cardiovascular event (MACE) including CV death
Measured: First event during follow-up 2010-2022
Age at first MACE
mean age at first MACE for the groups
Measured: First event during follow-up 2010-2022
All cause death
death from any cause during follow-up
Measured: 2010-2022
Secondary outcomes (1)
Risk reduction with PAP
Survival analysis between both OSA groups only stratified by PAP adherence (hours/night)
Measured: 2010-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 Jan 2025
- Primary completion8 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148,467 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Swedish Heart Lung Foundation, Göteborg University, Lund University, Uppsala University
- Responsible party
- Principal investigator, Sven Svedmyr, Vastra Gotaland Region
- Investigators
- Sven Svedmyr, MD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930989
- Sponsor's protocol ID
- SERA Lund DNR:2025-00712-02
- Acronym
- DISCOVERY-HT
- Status last verified
- May 2025
- First submitted
- 8 Apr 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be made available from the discovery cohort on case to case basis after applying to the discovery cohort registry holder after reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twin Threat of OSA and Hypertension on Mortality/CV-risk and Protective Effect by Positive Airway Pressure Treatment.
- ClinicalTrials.gov ID
- NCT06930989
- Acronym / sponsor ID
- DISCOVERY-HT / SERA Lund DNR:2025-00712-02
- Conditions
- Hypertension, OSA - Obstructive Sleep Apnea, MACE, Survival Analysis, PAP
- Keywords
- Primary CV prevention, hypertension, OSA, PAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148,467 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Swedish Heart Lung Foundation, Göteborg University, Lund University, Uppsala University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hypertension and obstructive sleep apnea (OSA) | – | Device: Positive airway pressure (PAP)Patients with hypertension and positive airway pressure (PAP) treated OSA |
| OSA alone | – | Device: Positive airway pressure (PAP)Patients with PAP teated OSA but no hypertension |
| Hypertension control | – | –Patients of control population with hypertension |
| Healthy controls | – | –Control population without hypertension and without OSA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive airway pressure (PAP)Intervention as part of routine clinical care. Data from national registries. | Device | Hypertension and obstructive sleep apnea (OSA), OSA alone |
Primary outcome
Major cardiovascular event (MACE)
Time frame: First event during follow-up 2010-2022
Major cardiovascular event (MACE) including CV death
Age at first MACE
Time frame: First event during follow-up 2010-2022
mean age at first MACE for the groups
All cause death
Time frame: 2010-2022
death from any cause during follow-up
1 secondary outcome
Risk reduction with PAP
Time frame: 2010-2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: Yes. Data can be made available from the discovery cohort on case to case basis after applying to the discovery cohort registry holder after reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Svedmyr, MD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and OSA - Obstructive Sleep Apnea, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiovascular event (MACE) (time frame: First event during follow-up 2010-2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.