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Effects of Metroprolol and Amlodipine on Blood Pressure Variation in Hypertensive Sleep Apnea Syndrome

Information source: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sleep Apnea Syndrome; Hypertension

Intervention: Amlodipine (Drug); metoprolol (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: First Affiliated Hospital of Harbin Medical University

Overall contact:
Yue Li, PHD, Phone: 86-451-85555673, Email: ly99ly@vip.163.com

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.

Clinical Details

Official title: The Study Was Approved by the Ethics Committee of Our Institution, Which is Accredited by the Office of Human Research Protection as an Institutional Review Board

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: 24-hour Ambulatory Blood Pressure Monitoring

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Yue Li, PHD, Phone: 86-451-85555673, Email: ly99ly@vip.163.com

Twenty-four-hour ambulatory BP monitoring, Budapest, Hungary; Recruiting
Jingyan Piao, MM, Phone: 86-451-85555333, Email: 411483521@qq.com
Yujiao Pan, MM, Phone: 86-451-85555671, Email: panyujiao@163.com

Portable polysomnography, Suzhou, Jiangsu, China; Recruiting
Jing Yan Piao, MM, Phone: 86-451-85555333, Email: 411483521@qq.com

Additional Information

Starting date: October 2013
Last updated: April 2, 2015

Page last updated: August 23, 2015

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