Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)

Not Applicable

Completed

• Conditions: Hypertension; Obstructive Sleep Apnea
• Interventions: Drug: Olmesartan and Azelnidipine

• Registration Number: NCT01028534
• Lead Sponsor: Kyoto University, Graduate School of Medicine

Brief Summary

The aim of the present study is to compare the effects of different types of antihypertensive drugs (angiotensin II receptor blockers and long-acting calcium channel blockers) in patients with hypertension and obstructive sleep apnea who are not controlled well with their hypertension after continuous positive airway pressure therapy.

Detailed Description

Obstructive sleep apnea (OSA) and hypertension have a significant interrelationship, and both disorders are well known risk factors for cardiovascular diseases (CVD). Treating them appropriately may improve the prognosis of the patients. Presently, continuous positive airway pressure (CPAP) therapy is the first-line therapy for OSA, and angiotensin II receptor blockers and long-acting calcium channel blockers for hypertension in Japan. Therefore, in the present study, we wanted to compare the effects of these different types of antihypertensive drugs on the control of blood pressure in patients with OSA whose hypertension is not controlled well after CPAP therapy.

Study Timeline

• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Study Start: 2010-07
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-01
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Apnea and hypopnea index of more than 20 /hr, and treated with CPAP
• Uncontrolled hypertension (defined as systolic blood pressure of more than 130 mmHg or diastolic blood pressure of more than 80 mmHg

Exclusion Criteria

• Cerebrovascular diseases, myocardial infarction, angina pectoris or heart failure within 6 months
• Uncontrolled arrhythmia
• Severe hepatic or renal disorders
• Having poor prognosis disorders such as malignant disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARB plus increased ARB	Olmesartan and Azelnidipine	angiotensin II receptor blockers for the first 3 months and increasing dose of angiotensin II receptor blockers for the next 3 months
CCB plus ARB	Olmesartan and Azelnidipine	calcium channel blockers for the first 3 months and adding angiotensin II receptor blockers for the next 3 months
ARB plus CCB	Olmesartan and Azelnidipine	angiotensin II receptor blockers for the first 3 months and adding calcium channel blockers for the next 3 months

Primary Outcome Measures

Name	Time	Method
Blood pressure	Six months

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life	Six months
Oxygen desaturation index	Six months
Pulse rate	Six months
Endothelial dysfunction	Six months
Sleep quality and sleepiness	Six months

Trial Locations

Locations (2)

Kirigaoka Tsuda Hospital; 🇯🇵 Kitakyushu, Japan

Kyoto University Hospital; 🇯🇵 Kyoto, Japan