A Phase 4 interventional study of Losartan and CPAP in Hypertension and Sleep Apnea, sponsored by Skaraborg Hospital. Completed at 1 site in Sweden. Open to participants aged 50 Years to 69 Years. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by Skaraborg Hospital · Phase 4, Interventional, and 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.
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.
1,423 studies on the registry are indexed under Apnea; 160 are open to participants now.
This study's enrollment of 90 is above the median of 51 across 966 interventional studies indexed under Apnea.
Browse Apnea studies →Skaraborg Hospital is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hypertensive Men and Women Without OSA on Losartan (n=30)
Drug: Losartan
Hypertensive Men and Women With OSA on Losartan (n=30)
Drug: Losartan
Hypertensive Men and Women with OSA on Losartan and CPAP (n=30)
Drug: Losartan · Other: CPAP
Losartan 50 mg daily during 6 + 6 weeks
Also known as: Cozaar
CPAP during the second 6 week-period
Also known as: Auto-CPAP
24 h blood pressure (mean blood pressure; mmHg)
Time frame: Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively
Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkers
Time frame: Changes from Baseline in Biomarkers at 6 and 12 weeks, respectively
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Skaraborg Hospital