Effects of Metoprolol and Amlodipine on Cardiac Remodeling, Arrhythmias and Blood Pressure Variation in Hypertensive Patients With Sleep Apnea Syndrome
Primary Purpose
Sleep Apnea Syndrome, Hypertension
Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Amlodipine
metoprolol
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea Syndrome focused on measuring hypertension, Sleep apnea syndrome, Amlodipine, metoprolol
Eligibility 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.
Sites / Locations
- Portable polysomnographyRecruiting
- Twenty-four-hour ambulatory BP monitoringRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
OSA-amlodipine
OSA-metoprolol
Arm Description
To observe the effects of amlodipine (5mg) on blood pressure variation after 12 weeks of treatment
To observe the effects of metoprolol (47.5mg) on blood pressure variation after 12 weeks of treatment
Outcomes
Primary Outcome Measures
24-hour Ambulatory Blood Pressure Monitoring
Secondary Outcome Measures
24-hour continuous ambulatory electrocardiography
Ultrasonic echocardiography
Full Information
NCT ID
NCT02408172
First Posted
March 12, 2015
Last Updated
February 13, 2017
Sponsor
First Affiliated Hospital of Harbin Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02408172
Brief Title
Effects of Metoprolol and Amlodipine on Cardiac Remodeling, Arrhythmias and Blood Pressure Variation in Hypertensive Patients With Sleep Apnea Syndrome
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 Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Harbin Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome, Hypertension
Keywords
hypertension, Sleep apnea syndrome, Amlodipine, metoprolol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OSA-amlodipine
Arm Type
Experimental
Arm Description
To observe the effects of amlodipine (5mg) on blood pressure variation after 12 weeks of treatment
Arm Title
OSA-metoprolol
Arm Type
Experimental
Arm Description
To observe the effects of metoprolol (47.5mg) on blood pressure variation after 12 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
Amlodipine was given orally in a dose of 5mg/day to treat patients in the OSA-amlodipine group for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
metoprolol
Intervention Description
Metoprolol was given orally in a dose of 47.5mg/day to treat patients in the OSA-metoprolol group for 12 weeks.
Primary Outcome Measure Information:
Title
24-hour Ambulatory Blood Pressure Monitoring
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
24-hour continuous ambulatory electrocardiography
Time Frame
up to 3 years
Title
Ultrasonic echocardiography
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Li, PHD
Phone
86-451-85555673
Email
ly99ly@vip.163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Shi, MM
Phone
86-451-85555672
Email
yidashijing@163.com
Facility Information:
Facility Name
Portable polysomnography
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Yan Piao, MM
Phone
86-451-85555333
Email
411483521@qq.com
Facility Name
Twenty-four-hour ambulatory BP monitoring
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingyan Piao, MM
Phone
86-451-85555333
Email
411483521@qq.com
First Name & Middle Initial & Last Name & Degree
Yujiao Pan, MM
Phone
86-451-85555671
Email
panyujiao@163.com
12. IPD Sharing Statement
Learn more about this trial
Effects of Metoprolol and Amlodipine on Cardiac Remodeling, Arrhythmias and Blood Pressure Variation in Hypertensive Patients With Sleep Apnea Syndrome
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