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

Sponsor

First Affiliated Hospital of Harbin Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02513927

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: metoprolol Drug: Nifedipine	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2017

Anticipated Study Completion Date :

Oct 1, 2018

Arms and Interventions

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.

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

Primary Outcome Measures

24-hour Ambulatory Blood Pressure Monitoring [3 years]

Secondary Outcome Measures

plasma uric acid level [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.