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| Sponsor: | Skaraborg Hospital |
|---|---|
| Information provided by: | Skaraborg Hospital |
| ClinicalTrials.gov Identifier: | NCT00701428 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Phase 4 Study of Losartan in Hypertensive Men With Obstructive Sleep Apnea Before and After Continuous Positive Airway Pressure (CPAP) Treatment |
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Hypertensive Men Without OSA on Losartan (n=30)
|
Drug: Losartan
Losartan 50 mg daily during 6 + 6 weeks
|
|
2: Active Comparator
Hypertensive Men With OSA on Losartan (n=30)
|
Drug: Losartan
Losartan 50 mg daily during 6 + 6 weeks
|
|
3: Experimental
Hypertensive Men with OSA on Losartan and CPAP (n=30)
|
Drug: Losartan
Losartan 50 mg daily during 6 + 6 weeks
Other: CPAP
CPAP during the second 6 week-period
|
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. We will include 90 otherwise healthy, untreated hypertensive men (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:
Exclusion Criteria:
Contacts and Locations| Contact: Yuksel Peker, Assoc. Prof. | +46500431000 ext 1894 | yuksel.peker@vgregion.se |
| Sweden, West Gotaland | |
| 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
| Responsible Party: | Sleep Medicine Unit, Skaraborg Hospital ( Yuksel Peker, MD, PhD, Associate Professor ) |
| Study ID Numbers: | VGSKAS-12916, FoU Sweden, nr 8751 |
| Study First Received: | June 13, 2008 |
| Last Updated: | November 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00701428 History of Changes |
| Health Authority: | Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board |
|
Hypertension Sleep Apnea Angiotensin II antagonist CPAP |
|
Losartan Sleep Apnea Syndromes Molecular Mechanisms of Pharmacological Action Apnea Respiration Disorders Nervous System Diseases Vascular Diseases Dyssomnias Sleep Disorders Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Sleep Disorders, Intrinsic Angiotensin II Type 1 Receptor Blockers Signs and Symptoms Respiratory Tract Diseases Therapeutic Uses Signs and Symptoms, Respiratory Cardiovascular Diseases Anti-Arrhythmia Agents Hypertension |