Impact of Losartan in hypertensive men with obstructive sleep apnea - LOSARTANPAP
- Conditions
- Hypertension and obstructive sleep apnea (OSA)
- Registration Number
- EUCTR2008-000869-38-SE
- Lead Sponsor
- Skaraborg Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 90
-Men
-Age 50-69 years
-Body-Mass-Index <35 kg/m2
-Systolic Blood Pressures >=140 mmHg and/or Diastolic Blood Pressure >=95 mmHg
-No known clinical disease except hypertension
-No cardiovascular medication
-Apnea-Hypopnea-Index (AHI) <5/h (no obstructive sleep apnea) or AHI>=15/h (obstructive sleep apnea) by sleep-recording
-Written informed consent from the participant
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
AHI 5-14.9/h by sleep-recording
Manifest diabetes, liver- or kidney disease according to blood samples at screening
Signs of atrial fibrillation or former myocardial infarction at electrocardiogram
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To address if blood pressure response to Losartan is less adequate in hypertensive men with obstructive sleep apnea (OSA) compared to those without this state. <br><br>;Secondary Objective: To address if these groups differ from eachother in response to Losartan regarding the neuroendocrine hormones and cardiovascular biomarkers. <br><br>We will also address if treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) has an additive effect regarding blood pressure response to Losartan in this group.<br>;Primary end point(s): Blood-pressure response (ambulatory 24-h blood pressure) after 6 weeks of Losartan (50 mg) daily compared to baseline in patients with and without obstructive sleep apnea.<br><br>Blood-pressure response (ambulatory 24-h blood pressure) after another 6 week-period in subgroup of hypertensive patients with obstructive sleep apnea with Losartan only compared to the treatment with Losartan and CPAP
- Secondary Outcome Measures
Name Time Method