Clinical trial NCT02513927: The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese
Official title: The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese: a Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hypertension
Keywords: Blood pressure variability
CCB
beta-receptor blockers
heart rate
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2015-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 24-hour Ambulatory Blood Pressure Monitoring
timeFrame: 3 years
Secondary outcomes:
measure: plasma uric acid level
timeFrame: 3 years
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Twenty-four-hour ambulatory BP monitoring
Study officials:
References: