Study of Antihypertensive Treatment in Patients with High-normal Blood Pressure and Risk Factors (CHINOM)

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TRC-10000848
• Date of registration: 2010-04-14
• Prospective Registration: No
• Primary sponsor: Beijing Fu Wai Hospital
• Public title: Study of Antihypertensive Treatment in Patients with High-normal Blood Pressure and Risk Factors (CHINOM)
• Scientific title: Study of Antihypertensive Treatment in Patients with High-normal Blood Pressure and Risk Factors
• Date of first enrolment: 2007-04-01
• Target sample size: Group A:4500;Group B:4500;Group C1:2250;Group C2:2250;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=8688
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Lisheng Liu

• Name: Yuqing Zhang
• Affiliation: Beijing Fu Wai Hospital

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria:
1. Age: 45-79 (male) or 50-79 (female) years old;
2. Blood pressure: 130<=SBP<140mmHg and/or 85<=DBP<90mmHg;
3. At least one of other cardiovascular risk factors;
4. Informed consent obtained Cardiovascular risk factors:
(1) Waist Circumference (WC): Male>=85cm, female>=80cm or overweight (BMI >25kg/m2);
(2) TC>=220mg/dL or TG>=150mg/dL or HDL-C<40mg/dL;
(3) Glucose Level: 6.1<=FPG<7.0mmol/L and/or 7.8<=OGTT 2hPG<11.1mmol/L;
(4) Current smoker.
5. Cardiac insufficiency (NYHA II);
6. Proteinurea or microalbuminruia;
7. Family history of early onset of cardiovascular diseases;
8. Family history of hypertension or diabetes;
9. Age> 65 years old.
Exclusion criteria: 1. Diabetes mellitus (FPG>=7.0mmol/L and/or OGTT 2hPG>=11.1mmol/L);
2. Hypertensive patients (SBP 3 140 mmHg and/or DBP 3 90 mmHg);
3. Patients participating in any other studies within three months or concomitantly;
4. Presence of renal dysfunction, Cr >133 mmol/L, or BUN >14.2mmol/L;
5. Presence of hepatic dysfunction (AST and/or ALT is 3 times higher than normal limit);
6. Hypersensitivity to agents used in this study;
7. Stroke or myocardial infarction within 6 months of the enrollment;
8. Balloon dilatation of coronary arteries or bypass operation within 2 months prior to the study;
9. Presence of malignant tumors or other serious diseases;
10. Pregnant or lactating women; women in reproductive age not using recognized contraceptive methods;
11. Gout or serum uric acid higher than 8.0mg/dL;
12. Incapacity or unwillingness to sigh the informed consent;
13. Incapacity for follow up;
14. Other reasons that on the discretion of the investigators that not appropriate to participate into the study.

Age minimum: 45
Age maximum: 79
Gender: Both

Health Condition(s) or Problem(s) studied

Patients with High-normal Blood Pressure and Risk Factors

Intervention(s)

Group A:Telmisartan 40 mg once a day;Group B:Indapamide 1.5mg once every two days ;Group C1:placebo half a pill once a day;Group C2:placebo half a pill once a day;

Primary Outcome(s)

Combined cardiovascular event;

Secondary Outcome(s)

stroke, hospitalized TIA, MI, hospitalized angina, hospitalized heart failure, peripheral arterial disease, tumor, all cause death, renal function failure;Development of hypertension or onset of diabete;

Source(s) of Monetary Support

The National Key Technology R&D Program; Beijing Double-Crane Pharmaceutical Co., Ltd