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

Study Overview
=================
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.

Official Title
-----------------
Comparison of the Effects of Different Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea, Hypertension

Intervention / Treatment
-----------------
* Drug: Olmesartan and Azelnidipine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ARB plus increased ARB<br>angiotensin II receptor blockers for the first 3 months and increasing dose of angiotensin II receptor blockers for the next 3 months | Drug: Olmesartan and Azelnidipine<br>* Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, increase Olmesartan to 40mg per day for the next 3 months Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, add Azelnidipine 16mg per day for the next 3 months Azelnidipine 16mg per day for 3 months, and, if hypertension is not controlled, add Olmesartan 20mg per day for the next 3 months<br>* Other names: Azelnidipine (long-acting calcium channel blockers: CCB);|
| Active Comparator: ARB plus CCB<br>angiotensin II receptor blockers for the first 3 months and adding calcium channel blockers for the next 3 months | Drug: Olmesartan and Azelnidipine<br>* Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, increase Olmesartan to 40mg per day for the next 3 months Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, add Azelnidipine 16mg per day for the next 3 months Azelnidipine 16mg per day for 3 months, and, if hypertension is not controlled, add Olmesartan 20mg per day for the next 3 months<br>* Other names: Azelnidipine (long-acting calcium channel blockers: CCB);|
| Active Comparator: CCB plus ARB<br>calcium channel blockers for the first 3 months and adding angiotensin II receptor blockers for the next 3 months | Drug: Olmesartan and Azelnidipine<br>* Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, increase Olmesartan to 40mg per day for the next 3 months Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, add Azelnidipine 16mg per day for the next 3 months Azelnidipine 16mg per day for 3 months, and, if hypertension is not controlled, add Olmesartan 20mg per day for the next 3 months<br>* Other names: Azelnidipine (long-acting calcium channel blockers: CCB);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen desaturation index |  | Six months | 
| Pulse rate |  | Six months | 
| Endothelial dysfunction |  | Six months | 
| Sleep quality and sleepiness |  | Six months | 
| Health-related quality of life |  | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Continuous positive pressure ventilation, Blood pressure, Oxygen desaturation index, Endothelial dysfunction, Patient reported measurement