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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Obstructive Sleep Apnea
• Intervention / Treatment: Drug: Olmesartan and Azelnidipine

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Kitakyushu, Japan
    • Kirigaoka Tsuda Hospital
  • Kyoto, Japan
    • Kyoto University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARB plus increased ARB; 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; 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; Other Names: Olmesartan (angiotensin II receptor blockers: ARB); Azelnidipine (long-acting calcium channel blockers: CCB)
Active Comparator: ARB plus CCB; angiotensin II receptor blockers for the first 3 months and adding calcium channel blockers for the next 3 months	Drug: Olmesartan and Azelnidipine; 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; Other Names: Olmesartan (angiotensin II receptor blockers: ARB); Azelnidipine (long-acting calcium channel blockers: CCB)
Active Comparator: CCB plus ARB; calcium channel blockers for the first 3 months and adding angiotensin II receptor blockers for the next 3 months	Drug: Olmesartan and Azelnidipine; 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; Other Names: Olmesartan (angiotensin II receptor blockers: ARB); Azelnidipine (long-acting calcium channel blockers: CCB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood pressure	Six months

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Kyoto University, Graduate School of Medicine
• Investigators: Principal Investigator: Kazuo Chin, MD, PhD, Graduate School of Medicine, Kyoto University; Principal Investigator: Toru Oga, MD, PhD, Graduate School of Medicine, Kyoto University

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 8, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (Estimate): December 9, 2009

Study Record Updates

• Last Update Posted (Estimate): April 3, 2015
• Last Update Submitted That Met QC Criteria: April 1, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Endothelial dysfunction; Blood pressure; Continuous positive pressure ventilation; Oxygen desaturation index; Patient reported measurement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Apnea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Angiotensin II Type 1 Receptor Blockers; Vasoconstrictor Agents; Olmesartan; Olmesartan Medoxomil; Calcium Channel Blockers; Angiotensin II; Angiotensin Receptor Antagonists
• Other Study ID Numbers: C359kyoto