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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan | Experimental | capsule,40mg per day,2 months |
|
| Hydrochlorothiazide | Experimental | tablet, 25mg per day, 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug | capsule,40mg per day,2 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| The between-group difference of the blood pressure control rates before and after the intervention of the subjects | The patients whose SBP is less than 140 (150 for the old) and DBP less than 90 are thought to be controlled. | 2 months |
| The between-group difference of the changing ranges of FBG testing results before and after the intervention of the subjects |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhang Pu Hong | The George Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Traditional Medicine Hospital of Anguo | Baoding | Hebei | 071200 | China | ||
| Boye hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28509725 | Derived | Zhang P, Wang H, Sun L, Zhang J, Xi Y, Wu Y, Yan LL, Li X, Sun N. Telmisartan and hydrochlorothiazide antihypertensive treatment in high sodium intake population: a randomized double-blind trial. J Hypertens. 2017 Oct;35(10):2077-2085. doi: 10.1097/HJH.0000000000001407. |
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| Hydrochlorothiazide | Drug | tablet, 25mg per day, 2 months |
|
|
Blood samples will be collected at baseline and the end of 2-month intervention for FBG test. |
| 2 months |
| The between-group difference of the incidence rates of hypokalemia after the intervention of the subjects | Blood samples will be collected at baseline and the end of 2-month intervention for test | 2 months |
| Baoding |
| Hebei |
| 071300 |
| China |
| Lixian chinese traditional medicine hospital | Baoding | Hebei | 071400 | China |
| Gaoyang hospital | Baoding | Hebei | 071500 | China |
| People's hospital in Rongcheng | Baoding | Hebei | 071700 | China |
| Mancheng Hospital | Baoding | Hebei | 072150 | China |
| Shunping Hospital | Baoding | Hebei | 072250 | China |
| People's hospital of Tangxian | Baoding | Hebei | 072350 | China |
| Wangdu hospital | Baoding | Hebei | 072450 | China |
| Gaobeidian hospital | Baoding | Hebei | 074000 | China |
| Central hospital in Baigou | Baoding | Hebei | 074004 | China |
| The second hospital of Lai Shui | Baoding | Hebei | 074100 | China |
| Wenan Hospital | Lanfang | Hebei | 065800 | China |
| Dacheng chinese traditional medicine hospital | Langfang | Hebei | 065900 | China |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D036881 | Long-Term Synaptic Depression |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
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