Effects of Metoprolol and Amlodipine on Cardiac Remodeling, Arrhythmias and Blood Pressure Variation in Hypertensive Patients With Sleep Apnea Syndrome

Phase 2

• Conditions: Sleep Apnea Syndrome; Hypertension
• Interventions: Drug: Amlodipine; Drug: metoprolol

• Registration Number: NCT02408172
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief Summary

Obstructive sleep apnea (OSA) is a highly prevalent chronic sleep disorder that affects 3% to 7% in middle aged individuals and increases with age. OSA has been identified as the most common secondary cause associated with resistant hypertension. There is evidence that compared with older patients, the risk of hypertension in OSA patients may be particularly pronounced in younger adult ones (less than 50 years).

Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP. In addition, it has been found that hypoxia condition in pneumoconiosis patients was closely associated with exaggerated BPV in ambulatory BP. However, the selections of antihypertensive drugs remain yet not very clearly for hypertensive patients combined with OSA.

Detailed Description

Obstructive sleep apnea (OSA) is a highly prevalent chronic sleep disorder that affects 3% to 7% in middle aged individuals and increases with age. It is considered an important independent contributing factor for the development of hypertension, diabetes and heart rhythm disorders. The prevalence of arterial hypertension has been reported to reach 50% of patients with OSA. OSA has been identified as the most common secondary cause associated with resistant hypertension. There is evidence that compared with older patients, the risk of hypertension in OSA patients may be particularly pronounced in younger adult ones (less than 50 years).

Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP. In addition, it has been found that hypoxia condition in pneumoconiosis patients was closely associated with exaggerated BPV in ambulatory BP. However, the selections of antihypertensive drugs remain yet not very clearly for hypertensive patients combined with OSA.

Study Timeline

• Study Start: 2013-10
• Status Verified: 2014-10
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-15
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Men aged between 18 and 75 included years old, and
• Postmenopausal women who are no more than 75 years older.
• Patients with essential mild to moderate uncomplicated hypertension (DBP<110mmHg and SBP<180mmHg measured with a validated automatic device in sitting position) after initiation or intensification of appropriate healthy lifestyle modification,
• Without antihypertensive treatment in 2 weeks.

Exclusion Criteria

• History of cerebrovascular disease: ischemic stroke, cerebral haemorrhage and TIA.
• History of cardiovascular disease:unstable angina, myocardial infarction, coronary revascularization and congestive heart failure.
• History of renal impairment.
• History of Type I diabetes mellitus or Type II diabetes uncontrolled.
• History of liver impairment.
• History of alcoholism or drug abuse.
• Known symptomatic orthostatic hypotension.
• Contra-indications to treatment with investigate products.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OSA-amlodipine	Amlodipine	To observe the effects of amlodipine (5mg) on blood pressure variation after 12 weeks of treatment
OSA-metoprolol	metoprolol	To observe the effects of metoprolol (47.5mg) on blood pressure variation after 12 weeks of treatment

Primary Outcome Measures

Name	Time	Method
24-hour Ambulatory Blood Pressure Monitoring	up to 3 years

Secondary Outcome Measures

Name	Time	Method
Ultrasonic echocardiography	up to 3 years
24-hour continuous ambulatory electrocardiography	up to 3 years

Trial Locations

Locations (2)

Portable polysomnography; 🇨🇳 Suzhou, Jiangsu, China

Twenty-four-hour ambulatory BP monitoring; 🇭🇺 Budapest, Hungary