In this research, the investigators aim to compare the antihypertensive efficacy and safety of monotherapy of routine dose angiotensin receptor antagonist telmisartan (ARB) and diuretic Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate hypertension. The research will be conducted in the rural area in Hebei province, where people have a high sodium diet in their daily life. The 1200 eligible subjects will be drawn from 12 local county-level hospitals. Subjects will be randomly allocated in double-blind manner into ARB or HCTZ group to be administered telmisartan 40mg per day or hydrochlorothiazide 25mg per day respectively. After two-month treatment, the investigators will evaluate and compare the antihypertensive efficacy and safety between the two therapies. The first objective of the research is to compare the antihypertensive efficacy of monotherapy of routine dose of angiotensin receptor antagonist telmisartan (ARB) and diuretic Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate hypertension.The second objective is to compare the safety between the two therapies applied. Null Hypothesis-H0: There will be no efficacy differences of lowering the systolic pressure between treating high sodium intake patients with mild to moderate hypertension with telmisartan and hydrochlorothiazide.Alternative Hypothesis-H1: There will be efficacy differences of lowering the systolic pressure between treating high sodium intake patients with mild to moderate hypertension with telmisartan and hydrochlorothiazide. This research is a multicenter randomized double-blinded parallel controlled trial targeting on high sodium intake patients with mild to moderate hypertension in China. The eligible 1200 subjects will be randomly divided into ARB and HCTZ two groups, treated with monotherapy of telmisartan 40mg per day or hydrochlorothiazide 25mg per day respectively. Then, the compliance of the patients will be followed after a week. The investigators will evaluate the efficacy of blood pressure control and the safety of the medicines after one month and two months of the beginning of therapies. Figure 1 shows the research process.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,410
capsule,40mg per day,2 months
tablet, 25mg per day, 2 months
Chinese Traditional Medicine Hospital of Anguo
Baoding, Hebei, China
Boye hospital
Baoding, Hebei, China
Lixian chinese traditional medicine hospital
Baoding, Hebei, China
Gaoyang hospital
Baoding, Hebei, China
People's hospital in Rongcheng
Baoding, Hebei, China
Mancheng Hospital
Baoding, Hebei, China
Shunping Hospital
Baoding, Hebei, China
People's hospital of Tangxian
Baoding, Hebei, China
Wangdu hospital
Baoding, Hebei, China
Gaobeidian hospital
Baoding, Hebei, China
...and 4 more locations
The difference between 2 groups of the decrease ranges of SBPs before and after the intervention of the subjects
We will measure the SBP for all the participants( around 1400) at baseline and 2\\4\\8 weeks after intervention with Omron electronic sphygmomanometer HBP - 1300. We will compare the differences between 2 groups at all 4 time points.
Time frame: 2 months
The between-group difference of the decrease ranges of DBPs before and after the intervention of the subjects
We will measure the DBP for all the participants( around 1400) at baseline and 2\\4\\8 weeks after intervention with Omron electronic sphygmomanometer HBP - 1300. We will compare the differences between 2 groups at all 4 time points.
Time frame: 2 months
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