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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02513927
• Other study ID #: HT-2
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 21, 2015
• Last updated: September 28, 2015
• Start date: August 2015
• Est. completion date: October 2018

Study information

• Verified date: September 2015
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Yue Li, PHD
• Phone: 86-451-85555673
• Email: ly99ly[@]vip.163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Hungary	Twenty-four-hour ambulatory BP monitoring	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour Ambulatory Blood Pressure Monitoring		3 years	Yes
Secondary	plasma uric acid level		3 years	Yes