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

September 28, 2015 updated by: First Affiliated Hospital of Harbin Medical University

The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese: a Randomized Crossover Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Twenty-four-hour ambulatory BP monitoring
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24-hour Ambulatory Blood Pressure Monitoring
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
plasma uric acid level
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

July 21, 2015

First Submitted That Met QC Criteria

July 30, 2015

First Posted (Estimate)

August 3, 2015

Study Record Updates

Last Update Posted (Estimate)

September 30, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HT-2

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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