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The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese

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ClinicalTrials.gov Identifier: NCT02513927
Recruitment Status : Unknown
Verified September 2015 by First Affiliated Hospital of Harbin Medical University.
Recruitment status was:  Recruiting
First Posted : August 3, 2015
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: metoprolol Drug: Nifedipine Phase 2 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese: a Randomized Crossover Study
Study Start Date : August 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A
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.
 Drug: metoprolol
Metoprolol was given orally in a dose of 95 mg/day to treat patients in the metoprolol group for 12 weeks.

Drug: Nifedipine
Nifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine group for 12 weeks.
Active Comparator: B
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.
 Drug: metoprolol
Metoprolol was given orally in a dose of 95 mg/day to treat patients in the metoprolol group for 12 weeks.

Drug: Nifedipine
Nifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine group for 12 weeks.


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

Secondary Outcome Measures :
  1. plasma uric acid level [ Time Frame: 3 years ]

Eligibility Criteria
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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
  • 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.
Contacts and Locations
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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): NCT02513927


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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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
More Information
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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT02513927    
Other Study ID Numbers: HT-2
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015
Keywords provided by First Affiliated Hospital of Harbin Medical University:
Blood pressure variability
CCB
beta-receptor blockers
heart rate
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Nifedipine
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
 Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents