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

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ClinicalTrials.gov Identifier: NCT02408172
Recruitment Status : Unknown
Verified October 2014 by First Affiliated Hospital of Harbin Medical University.
Recruitment status was:  Recruiting
First Posted : April 3, 2015
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Sleep Apnea Syndrome Hypertension Drug: Amlodipine Drug: metoprolol Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : October 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: OSA-amlodipine
To observe the effects of amlodipine (5mg) on blood pressure variation after 12 weeks of treatment
Drug: Amlodipine
Amlodipine was given orally in a dose of 5mg/day to treat patients in the OSA-amlodipine group for 12 weeks.

Experimental: OSA-metoprolol
To observe the effects of metoprolol (47.5mg) on blood pressure variation after 12 weeks of treatment
Drug: metoprolol
Metoprolol was given orally in a dose of 47.5mg/day to treat patients in the OSA-metoprolol group for 12 weeks.




Primary Outcome Measures :
  1. 24-hour Ambulatory Blood Pressure Monitoring [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. 24-hour continuous ambulatory electrocardiography [ Time Frame: up to 3 years ]
  2. Ultrasonic echocardiography [ Time Frame: up to 3 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408172


Contacts
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Contact: Yue Li, PHD 86-451-85555673 ly99ly@vip.163.com
Contact: Jing Shi, MM 86-451-85555672 yidashijing@163.com

Locations
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China, Jiangsu
Portable polysomnography Recruiting
Suzhou, Jiangsu, China
Contact: Jing Yan Piao, MM    86-451-85555333    411483521@qq.com   
Hungary
Twenty-four-hour ambulatory BP monitoring Recruiting
Budapest, Hungary
Contact: Jingyan Piao, MM    86-451-85555333    411483521@qq.com   
Contact: Yujiao Pan, MM    86-451-85555671    panyujiao@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University

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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT02408172     History of Changes
Other Study ID Numbers: OSA-HT-1
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: October 2014
Keywords provided by First Affiliated Hospital of Harbin Medical University:
hypertension
Sleep apnea syndrome
Amlodipine
metoprolol
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Hypertension
Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Metoprolol
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists