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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Hypertensive Men and Women Without OSA on Losartan (n=30)

Group Type ACTIVE_COMPARATOR

Losartan

Intervention Type DRUG

Losartan 50 mg daily during 6 + 6 weeks

2

Hypertensive Men and Women With OSA on Losartan (n=30)

Group Type ACTIVE_COMPARATOR

Losartan

Intervention Type DRUG

Losartan 50 mg daily during 6 + 6 weeks

3

Hypertensive Men and Women with OSA on Losartan and CPAP (n=30)

Group Type EXPERIMENTAL

Losartan

Intervention Type DRUG

Losartan 50 mg daily during 6 + 6 weeks

CPAP

Intervention Type OTHER

CPAP during the second 6 week-period

Interventions

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Losartan

Losartan 50 mg daily during 6 + 6 weeks

Intervention Type DRUG

CPAP

CPAP during the second 6 week-period

Intervention Type OTHER

Other Intervention Names

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Cozaar Auto-CPAP

Eligibility Criteria

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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)