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First-line Antihypertensive Combinations comparison for Tibetan high-risk hypertension (FACT): study protocol for an open label, paralleled, multi-center randomized controlled trial

First-line Antihypertensive Combinations comparison for Tibetan high-risk hypertension (FACT): study protocol for an open label, paralleled, multi-center randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17014104
Enrollment
Unknown
Registered
2017-12-24
Start date
2018-12-01
Completion date
Unknown
Last updated
2018-07-09

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

Conditions

Hypertenison

Interventions

Intervention group 1:irbesartan/amlodipine (maximum titrated to 300/10 mg)
Intervention group 2:irbesartan/hydrochlorothiazide (maximum titrated to 300/25 mg)
Intervention group 3:amlodipine/hydrochlorothiazide (maximum titrated to 10/25 mg)

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with blood pressure=140/90mmHg for =3 times on separate days, or currently with on antihypertensive therapy; 2. Equal or older than 50 years old; 3. In Tibetan nationality; 4. Patients whose total cardiovascular risk are high or very high risk according to hypertensive guideline released by European society of hypertension[8]: (1) Grade 1 hypertension (SBP 140–159 and/or DBP 90–99mmHg) and = 3risk factors(Table 1); (2) Grade 2 hypertension (SBP 160–179 and/or DBP 100–109mmHg) and =2 risk factors(Table 1); (3) Grade 3 hypertension (SBP=180 and/or DBP=110mmHg); (4) With organ damage/cerebrovascular events; 5. Willing to participate with informed consent signed.

Exclusion criteria

Exclusion criteria: 1. Secondary hypertension; 2. Blood pressure>200/120 mmHg; 3. History of cerebrovascular events: Ischemic stroke, cerebral hemorrhage, transient ischemic attack verified by persistent hemiparesis, magnetic resonance imaging, computed tomography, angiography, or appropriate hospital records; 4. Coronary heart disease: Prior myocardial infarction, history of angina, myocardial revascularization with PCI or CABG, the above events should be appropriately documented by hospital records, angiographic reports or other relevant records; 5. Pregnant or with pregnancy plan; 6. Cancer; 7. Severely hepatic dysfunction; 8. Mental sickness without civil capacity; 9. Contraindications for irbesartan, amlodipine, and hydrochlorothiazide; 10. Unable to be followed-up; 11. Other situations not appropriate for study.

Design outcomes

Primary

MeasureTime frame
cardiovascular morbidity and mortality;

Secondary

MeasureTime frame
Cardiovascular morbidity;Cardiovascular mortality;All-cause mortality;

Countries

China

Contacts

Public ContactXiaoping Chen

West China Hospital, Sichuan University

mengqingtao9@163.com+86 18980601226

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026