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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02408172
Enrollment
20
Registered
2015-04-03
Start date
2013-10-31
Completion date
2017-12-31
Last updated
2017-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Sleep Apnea Syndrome

Keywords

hypertension, Sleep apnea syndrome, Amlodipine, metoprolol

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.

Interventions

DRUGAmlodipine

Amlodipine was given orally in a dose of 5mg/day to treat patients in the OSA-amlodipine group for 12 weeks.

DRUGmetoprolol

Metoprolol was given orally in a dose of 47.5mg/day to treat patients in the OSA-metoprolol group for 12 weeks.

Sponsors

First Affiliated Hospital of Harbin Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
24-hour Ambulatory Blood Pressure Monitoringup to 3 years

Secondary

MeasureTime frame
24-hour continuous ambulatory electrocardiographyup to 3 years
Ultrasonic echocardiographyup to 3 years

Countries

China, Hungary

Contacts

Primary ContactYue Li, PHD
ly99ly@vip.163.com86-451-85555673
Backup ContactJing Shi, MM
yidashijing@163.com86-451-85555672

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026