- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02408172
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Yue Li, PhD
- Phone Number: 86-451-85555673
- Email: ly99ly@vip.163.com
Study Contact Backup
- Name: Jing Shi, MM
- Phone Number: 86-451-85555672
- Email: yidashijing@163.com
Study Locations
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Jiangsu
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Suzhou, Jiangsu, China
- Recruiting
- Portable polysomnography
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Contact:
- Jing Yan Piao, MM
- Phone Number: 86-451-85555333
- Email: 411483521@qq.com
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-
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Budapest, Hungary
- Recruiting
- Twenty-four-hour ambulatory BP monitoring
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Contact:
- Jingyan Piao, MM
- Phone Number: 86-451-85555333
- Email: 411483521@qq.com
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Contact:
- Yujiao Pan, MM
- Phone Number: 86-451-85555671
- Email: panyujiao@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OSA-amlodipine
To observe the effects of amlodipine (5mg) on blood pressure variation after 12 weeks of treatment
|
Amlodipine was given orally in a dose of 5mg/day to treat patients in the OSA-amlodipine group for 12 weeks.
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Experimental: OSA-metoprolol
To observe the effects of metoprolol (47.5mg) on blood pressure variation after 12 weeks of treatment
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Metoprolol was given orally in a dose of 47.5mg/day to treat patients in the OSA-metoprolol group for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
24-hour Ambulatory Blood Pressure Monitoring
Time Frame: up to 3 years
|
up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
24-hour continuous ambulatory electrocardiography
Time Frame: up to 3 years
|
up to 3 years
|
Ultrasonic echocardiography
Time Frame: up to 3 years
|
up to 3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Disease
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Hypertension
- Syndrome
- Apnea
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Amlodipine
- Metoprolol
Other Study ID Numbers
- OSA-HT-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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