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Losartan in Hypertensive Men and Women With Sleep Apnea Before and on Continuous Positive Airway Pressure (CPAP) Treatment

Phase 4 Study of Losartan in Hypertensive Men and Women With Obstructive Sleep Apnea Before and After Continuous Positive Airway Pressure (CPAP) Treatment

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00701428
Acronym
LosartanPAP
Enrollment
90
Registered
2008-06-19
Start date
2008-06-30
Completion date
2014-02-28
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Sleep Apnea

Keywords

Hypertension, Sleep Apnea, Angiotensin II antagonist, CPAP

Brief 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.

Interventions

DRUGLosartan

Losartan 50 mg daily during 6 + 6 weeks

OTHERCPAP

CPAP during the second 6 week-period

Sponsors

Göteborg University
CollaboratorOTHER
Skaraborg Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 69 Years
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

Design outcomes

Primary

MeasureTime frame
24 h blood pressure (mean blood pressure; mmHg)Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively

Secondary

MeasureTime frame
Markers of sympathetic activity, RAAS-activity, cardiovascular biomarkersChanges from Baseline in Biomarkers at 6 and 12 weeks, respectively

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026