HypertensionPhase 4LosartanPAPNCT00701428
Losartan in Hypertensive Men and Women With Sleep Apnea Before and on Continuous Positive Airway Pressure (CPAP) Treatment
A Phase 4 study testing Losartan and CPAP in people with Hypertension and Sleep Apnea, run by Skaraborg Hospital at 1 site in Sweden.
Trial summary
Obstructive sleep apnea (OSA) is a highly prevalent condition in hypertensive patients. The renin-angiotension-aldosterone-system (RAAS) has a central role in blood pressure control. An angiotensin-II-antagonist, Losartan, is an effective antihypertensive drug. Read more about this study
- Who is it for?
- Ages 50 to 69 years
- Conditions the study is for
- Hypertension, Sleep Apnea
- What is being tested?
- Losartan and CPAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2008to Feb 2014
- Phase
- Phase 4
- 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 50 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index <35 kg/m2
- Systolic Blood Pressure >=140 mmHg and/or Diastolic Blood Pressure >=95 mmHg
- No known clinical disease except hypertension
- No cardiovascular medication
- Apnea-Hypopnea Index < 5/h (no OSA), or Apnea Hypopnea Index >=15/h (OSA)
Who cannot join
- Manifest diabetes, liver- or kidney disease Signs of atrial fibrillation or former myocardial infarction at electrocardiogram
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University of Gothenburg, Sahlgrenska Academy
Gothenburg, West Gotaland, SE 41685
About this study
Official title: Phase 4 Study of Losartan in Hypertensive Men and Women With Obstructive Sleep Apnea Before and After Continuous Positive Airway Pressure (CPAP) Treatment
Obstructive sleep apnea (OSA) is a highly prevalent condition in hypertensive patients. The renin-angiotension-aldosterone-system (RAAS) has a central role in blood pressure control. An angiotensin-II-antagonist, Losartan, is an effective antihypertensive drug. However, some patients respond to this drug worse than the others, and it is a clinical praxis to either increase the dosage and/or add another drug. There is limited data regarding the impact of antihypertensive drugs in OSA patients, i.e., whether or not OSA may constitute the subgroup of therapy-resistent hypertensive patients. In the literature, there is no data, either, whether or not CPAP treatment may have an additive blood pressure lowering impact in this certain subgroup.
Read the detailed description
OSA is a highly prevalent condition in hypertensive patients and the prevalence is even higher in patients with drug-resistant hypertension. The renin-angiotension-aldosterone-system (RAAS) has a central role in blood pressure control. An angiotensin-II-antagonist, Losartan, has an effective antihypertensive drug. However, some patients respond to this drug worse than the others, and it is a clinical praxis to either increase the dosage and/or add another drug. There is limited data regarding the impact of antihypertensive drugs in OSA patients, i.e., whether or not OSA may constitute the subgroup of therapy-resistent hypertensive patients. In the literature, there is no data, either, whether or not CPAP treatment may have an additive blood pressure lowering impact in this certain subgroup. The investigators will include 90 otherwise healthy, untreated hypertensive men and women(age 50-69 yrs, Body-Mass-Index <35 kg/m2; 60 patients with OSA, 30 non-OSA) as described above. Before start of treatment, fasting blood samples will be drawn regarding the neuroendocrine hormones (adrenaline, noradrenaline, plasma renin activity, angiotensin II,aldosterone, pro-BNP) and cardiovascular biomarkers (CRP,interleukines, cytokines). All subjects will start with Losartan 50 mg and 24 h- blood-pressure response and blood sample analysis will be compared between OSA and non-OSA subjects after 6 weeks of treatment. In the second 6-week period, all subjects will continue with Losartan while the half of the OSA group (n=30) will be randomized to CPAP and the other 30 patients will continue with Losartan only.
- Conditions
- Hypertension, Sleep Apnea
- Keywords
- Hypertension, Sleep Apnea, Angiotensin II antagonist, CPAP
- Medical subject headings
- Hypertension, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Cozaar
Losartan 50 mg daily during 6 + 6 weeks
CPAPOther
Also called Auto-CPAP
CPAP during the second 6 week-period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Hypertensive Men and Women Without OSA on Losartan (n=30) Receives: Drug: Losartan |
| 2 | Active comparator | Hypertensive Men and Women With OSA on Losartan (n=30) Receives: Drug: Losartan |
| 3 | Experimental | Hypertensive Men and Women with OSA on Losartan and CPAP (n=30) Receives: Drug: Losartan; Other: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 h blood pressure (mean blood pressure; mmHg)
Measured: Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively
Secondary outcomes (1)
Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers
Measured: Changes from Baseline in Biomarkers at 6 and 12 weeks, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skaraborg Hospital
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Yuksel Peker, Skaraborg Hospital
- Investigators
- Yuksel Peker, Prof., Principal investigator, Göteborg UniversityErik Thunström, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701428
- Sponsor's protocol ID
- VGSKAS-12916
- Other IDs
- FoU Sweden, nr 8751
- Acronym
- LosartanPAP
- Status last verified
- Oct 2020
- First submitted
- 13 Jun 2008
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thunstrom E, Manhem K, Rosengren A, Peker Y. Blood Pressure Response to Losartan and Continuous Positive Airway Pressure in Hypertension and Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2016 Feb 1;193(3):310-20. doi: 10.1164/rccm.201505-0998OC.
PubMed 26414380Thunstrom E, Manhem K, Yucel-Lindberg T, Rosengren A, Lindberg C, Peker Y. Neuroendocrine and Inflammatory Responses to Losartan and Continuous Positive Airway Pressure in Patients with Hypertension and Obstructive Sleep Apnea. A Randomized Controlled Trial. Ann Am Thorac Soc. 2016 Nov;13(11):2002-2011. doi: 10.1513/AnnalsATS.201602-126OC.
PubMed 27548072
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Losartan in Hypertensive Men and Women With Obstructive Sleep Apnea Before and After Continuous Positive Airway Pressure (CPAP) Treatment
- ClinicalTrials.gov ID
- NCT00701428
- Acronym / sponsor ID
- LosartanPAP / VGSKAS-12916
- Conditions
- Hypertension, Sleep Apnea
- Keywords
- Hypertension, Sleep Apnea, Angiotensin II antagonist, CPAP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Skaraborg HospitalOther government
- Collaborators
- Göteborg University
- Study start
- Jun 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Jun 2008 (estimated)
- 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.
Obstructive sleep apnea (OSA) is a highly prevalent condition in hypertensive patients. The renin-angiotension-aldosterone-system (RAAS) has a central role in blood pressure control. An angiotensin-II-antagonist, Losartan, is an effective antihypertensive drug. However, some patients respond to this drug worse than the others, and it is a clinical praxis to either increase the dosage and/or add another drug. There is limited data regarding the impact of antihypertensive drugs in OSA patients, i.e., whether or not OSA may constitute the subgroup of therapy-resistent hypertensive patients. In the literature, there is no data, either, whether or not CPAP treatment may have an additive blood pressure lowering impact in this certain subgroup.
Detailed description
OSA is a highly prevalent condition in hypertensive patients and the prevalence is even higher in patients with drug-resistant hypertension. The renin-angiotension-aldosterone-system (RAAS) has a central role in blood pressure control. An angiotensin-II-antagonist, Losartan, has an effective antihypertensive drug. However, some patients respond to this drug worse than the others, and it is a clinical praxis to either increase the dosage and/or add another drug. There is limited data regarding the impact of antihypertensive drugs in OSA patients, i.e., whether or not OSA may constitute the subgroup of therapy-resistent hypertensive patients. In the literature, there is no data, either, whether or not CPAP treatment may have an additive blood pressure lowering impact in this certain subgroup. The investigators will include 90 otherwise healthy, untreated hypertensive men and women(age 50-69 yrs, Body-Mass-Index <35 kg/m2; 60 patients with OSA, 30 non-OSA) as described above. Before start of treatment, fasting blood samples will be drawn regarding the neuroendocrine hormones (adrenaline, noradrenaline, plasma renin activity, angiotensin II,aldosterone, pro-BNP) and cardiovascular biomarkers (CRP,interleukines, cytokines). All subjects will start with Losartan 50 mg and 24 h- blood-pressure response and blood sample analysis will be compared between OSA and non-OSA subjects after 6 weeks of treatment. In the second 6-week period, all subjects will continue with Losartan while the half of the OSA group (n=30) will be randomized to CPAP and the other 30 patients will continue with Losartan only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: LosartanHypertensive Men and Women Without OSA on Losartan (n=30) |
| 2 | Active comparator | Drug: LosartanHypertensive Men and Women With OSA on Losartan (n=30) |
| 3 | Experimental | Drug: Losartan, Other: CPAPHypertensive Men and Women with OSA on Losartan and CPAP (n=30) |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body Mass Index <35 kg/m2
- Systolic Blood Pressure >=140 mmHg and/or Diastolic Blood Pressure >=95 mmHg
- No known clinical disease except hypertension
- No cardiovascular medication
- Apnea-Hypopnea Index < 5/h (no OSA), or Apnea Hypopnea Index >=15/h (OSA)
Key exclusion criteria (1 listed)
- Manifest diabetes, liver- or kidney disease Signs of atrial fibrillation or former myocardial infarction at electrocardiogram
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 |
|---|---|---|
| LosartanAlso: CozaarLosartan 50 mg daily during 6 + 6 weeks | Drug | 1, 2, 3 |
| CPAPAlso: Auto-CPAPCPAP during the second 6 week-period | Other | 3 |
Primary outcome
24 h blood pressure (mean blood pressure; mmHg)
Time frame: Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively
1 secondary outcome
Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers
Time frame: Changes from Baseline in Biomarkers at 6 and 12 weeks, respectively
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 22 Oct 2020.
- Results publication: PubMed 26414380Thunstrom E, Manhem K, Rosengren A, Peker Y. Blood Pressure Response to Losartan and Continuous Positive Airway Pressure in Hypertension and Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2016 Feb 1;193(3):310-20. doi: 10.1164/rccm.201505-0998OC.
- Results publication: PubMed 27548072Thunstrom E, Manhem K, Yucel-Lindberg T, Rosengren A, Lindberg C, Peker Y. Neuroendocrine and Inflammatory Responses to Losartan and Continuous Positive Airway Pressure in Patients with Hypertension and Obstructive Sleep Apnea. A Randomized Controlled Trial. Ann Am Thorac Soc. 2016 Nov;13(11):2002-2011. doi: 10.1513/AnnalsATS.201602-126OC.
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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.
Yuksel Peker, Prof. principal investigator
Göteborg University
Erik Thunström, PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Losartan and CPAP in people with Hypertension and Sleep Apnea, run by Skaraborg Hospital 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 5 inclusion and 1 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 22 Oct 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
24 h blood pressure (mean blood pressure; mmHg) (time frame: Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00701428, which also lists 2 linked publications.
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 22 Oct 2020.