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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02513927
Enrollment
40
Registered
2015-08-03
Start date
2015-08-31
Completion date
2018-10-31
Last updated
2015-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Blood pressure variability, CCB, beta-receptor blockers, heart rate

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.

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.

Interventions

DRUGmetoprolol

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

DRUGNifedipine

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

Sponsors

First Affiliated Hospital of Harbin Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
24-hour Ambulatory Blood Pressure Monitoring3 years

Secondary

MeasureTime frame
plasma uric acid level3 years

Countries

Hungary

Contacts

Primary ContactYue Li, PHD
ly99ly@vip.163.com86-451-85555673
Backup ContactJing Shi, MM
yidashijing@163.com86-451-85555672

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026