The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese
Primary Purpose
Hypertension
Status
Unknown status
Phase
Phase 2
Locations
Hungary
Study Type
Interventional
Intervention
metoprolol
Nifedipine
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension focused on measuring Blood pressure variability, CCB, beta-receptor blockers, heart rate
Eligibility Criteria
Inclusion Criteria:
- Men aged between 18 and 75 included years old
- 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
- Twenty-four-hour ambulatory BP monitoringRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
To observe the effects of metoprolol (95 mg) on blood pressure variation after 12 weeks of treatment.Then to observe the effects of Nifedipine (30 mg) on blood pressure variation after 12 weeks of treatment.
To observe the effects of Nifedipine (30 mg) on blood pressure variation after 12 weeks of treatment. Then to observe the effects of metoprolol (95 mg) on blood pressure variation after 12 weeks of treatment.
Outcomes
Primary Outcome Measures
24-hour Ambulatory Blood Pressure Monitoring
Secondary Outcome Measures
plasma uric acid level
Full Information
NCT ID
NCT02513927
First Posted
July 21, 2015
Last Updated
September 28, 2015
Sponsor
First Affiliated Hospital of Harbin Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02513927
Brief Title
The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese
Official Title
The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese: a Randomized Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2018 (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
Hypertension is one of the most common cardiovascular diseases, which is a major risk factor for stroke and cardiovascular events. 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.
At present, the normal range of BPV is not very clear. There are many studies about the effects of different kinds of drugs on blood pressure, but the clinical researches about the impacts of antihypertensive drugs on BPV are limited, and the conclusion is still controversial.
Detailed Description
Hypertension is one of the most common cardiovascular diseases, which is a major risk factor for stroke and cardiovascular events. 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.
The hypertension prevalences in the high latitude and cold regions are much higher than those in the low latitude and warm regions. In China, the prevalences of hypertension are gradually increased from the South to the North. Heilongjiang province is the "high-risk" region for hypertension, with a prevalence of 30.48%. This may be due to the combined effects of lower average temperature and higher intake of salt and saturated fatty acid, which Increased sympathetic nerve excitability, and eventually lead to elevation of blood pressure. Therefore, it is essential to formulate the best treatment of hypertension according with the physical characteristics of northern Chinese.
At present, the normal range of BPV is not very clear. There are many studies about the effects of different kinds of drugs on blood pressure, but the clinical researches about the impacts of antihypertensive drugs on BPV are limited, and the conclusion is still controversial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Blood pressure variability, CCB, beta-receptor blockers, heart rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
To observe the effects of metoprolol (95 mg) on blood pressure variation after 12 weeks of treatment.Then to observe the effects of Nifedipine (30 mg) on blood pressure variation after 12 weeks of treatment.
Arm Title
B
Arm Type
Active Comparator
Arm Description
To observe the effects of Nifedipine (30 mg) on blood pressure variation after 12 weeks of treatment. Then to observe the effects of metoprolol (95 mg) on blood pressure variation after 12 weeks of treatment.
Intervention Type
Drug
Intervention Name(s)
metoprolol
Intervention Description
Metoprolol was given orally in a dose of 95 mg/day to treat patients in the metoprolol group for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Intervention Description
Nifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine group for 12 weeks.
Primary Outcome Measure Information:
Title
24-hour Ambulatory Blood Pressure Monitoring
Time Frame
3 years
Secondary Outcome Measure Information:
Title
plasma uric acid level
Time Frame
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
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
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
The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese
We'll reach out to this number within 24 hrs