Losartan in Hypertensive Men and Women With Sleep Apnea Before and on Continuous Positive Airway Pressure (CPAP) Treatment
Condition: Hypertension; Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Hypertension
Study type: Interventional
Phase: Phase 4

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. 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.
    

Intervention name(s): Losartan; CPAP
Intervention type(s): Drug; Other
Intervention description(s): Losartan 50 mg daily during 6 + 6 weeks; CPAP during the second 6 week-period
Other intervention name(s): Cozaar; Auto-CPAP
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Sleep Apnea; Angiotensin II antagonist; CPAP