Losartan in Hypertensive Men and Women With Sleep Apnea Before and on Continuous Positive Airway Pressure (CPAP) Treatment (LosartanPAP)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Sleep Apnea |
Drug: Losartan Other: CPAP |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 24 h blood pressure (mean blood pressure; mmHg) [ Time Frame: Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively ] [ Designated as safety issue: No ]
- Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers [ Time Frame: Changes from Baseline in Biomarkers at 6 and 12 weeks, respectively ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Hypertensive Men and Women Without OSA on Losartan (n=30)
|
Drug: Losartan
Losartan 50 mg daily during 6 + 6 weeks
Other Name: Cozaar
|
|
Active Comparator: 2
Hypertensive Men and Women With OSA on Losartan (n=30)
|
Drug: Losartan
Losartan 50 mg daily during 6 + 6 weeks
Other Name: Cozaar
|
|
Experimental: 3
Hypertensive Men and Women with OSA on Losartan and CPAP (n=30)
|
Drug: Losartan
Losartan 50 mg daily during 6 + 6 weeks
Other Name: Cozaar
Other: CPAP
CPAP during the second 6 week-period
Other Name: Auto-CPAP
|
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.
Eligibility| Ages Eligible for Study: | 50 Years to 69 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Manifest diabetes, liver- or kidney disease Signs of atrial fibrillation or former myocardial infarction at electrocardiogram
Contacts and Locations| Contact: Yuksel Peker, Assoc. Prof. | +46500431000 ext 1894 | yuksel.peker@vgregion.se |
| Sweden | |
| Skaraborg Hospital | Recruiting |
| Skoevde, West Gotaland, Sweden, SE 51485 | |
| Contact: Yuksel Peker, Ass. Prof yuksel.peker@vgregion.se | |
| Principal Investigator: Yuksel Peker, Assoc. Prof. | |
| Principal Investigator: | Yuksel Peker, Assoc. Prof. | Skaraborg Hospital, Sweden |
More Information
No publications provided
| Responsible Party: | Yuksel Peker, MD, PhD, Associate Professor, Sleep Medicine Unit, Skaraborg Hospital |
| ClinicalTrials.gov Identifier: | NCT00701428 History of Changes |
| Other Study ID Numbers: | VGSKAS-12916, FoU Sweden, nr 8751 |
| Study First Received: | June 13, 2008 |
| Last Updated: | December 27, 2010 |
| Health Authority: | Sweden: Medical Products Agency Sweden: Regional Ethical Review Board |
Keywords provided by Skaraborg Hospital:
|
Hypertension Sleep Apnea Angiotensin II antagonist CPAP |
Additional relevant MeSH terms:
|
Apnea Hypertension Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Vascular Diseases Cardiovascular Diseases Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Losartan Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013