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

Kyoto University, Graduate School of Medicine

Status: Completed

Conditions: Hypertension; Obstructive Sleep Apnea

Treatments: Drug: Olmesartan and Azelnidipine

Study type: Interventional

Funder types: Other

Identifiers

NCT01028534

C359kyoto

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

ARB plus increased ARB

Active Comparator group

Description:

angiotensin II receptor blockers for the first 3 months and increasing dose of angiotensin II receptor blockers for the next 3 months

Treatment:

Drug: Olmesartan and Azelnidipine

ARB plus CCB

Active Comparator group

Description:

angiotensin II receptor blockers for the first 3 months and adding calcium channel blockers for the next 3 months

Treatment:

Drug: Olmesartan and Azelnidipine

CCB plus ARB

Active Comparator group

Description:

calcium channel blockers for the first 3 months and adding angiotensin II receptor blockers for the next 3 months

Treatment:

Drug: Olmesartan and Azelnidipine