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

NCT ID: NCT02513927

Last Updated: 2015-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-10-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Keywords

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Blood pressure variability CCB beta-receptor blockers heart rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

metoprolol

Intervention Type DRUG

Metoprolol was given orally in a dose of 95 mg/day to treat patients in the metoprolol group for 12 weeks.

Nifedipine

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

metoprolol

Intervention Type DRUG

Metoprolol was given orally in a dose of 95 mg/day to treat patients in the metoprolol group for 12 weeks.

Nifedipine

Intervention Type DRUG

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

Interventions

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metoprolol

Metoprolol was given orally in a dose of 95 mg/day to treat patients in the metoprolol group for 12 weeks.

Intervention Type DRUG

Nifedipine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Twenty-four-hour ambulatory BP monitoring

Budapest, Budapest, Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Yue Li, PHD

Role: CONTACT

Phone: 86-451-85555673

Email: [email protected]

Jing Shi, MM

Role: CONTACT

Phone: 86-451-85555672

Email: [email protected]

Facility Contacts

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Jingyan Piao, MM

Role: primary

Yujiao Pan, MM

Role: backup

Other Identifiers

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HT-2

Identifier Type: -

Identifier Source: org_study_id