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First-Line Antihypertensive comparison for Tibetan mild-moderate hypertension (FLAT): study protocol for a randomized crossover controlled trial

First-Line Antihypertensive comparison for Tibetan mild-moderate hypertension (FLAT): study protocol for a randomized crossover controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17014105
Enrollment
Unknown
Registered
2017-12-24
Start date
2018-03-01
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

Case series:three consecutively allocated 8-week treatment cycles with irbesartan, amlodipine and hydrochlorothiazide

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, without history of antihypertensive treatment; 2. Aged 18-80 years old; 3. In Tibetan nationality; 4. Patients whose total cardiovascular risk are mild or moderate according to hypertensive guideline released by European society of hypertension[8]: Grade 1 hypertension (SBP 140–159 and/or DBP 90–99mmHg) and= 2 risk factors (Table 1); Grade 2 hypertension (SBP 160–179 and/or DBP 100–109mmHg) and = 1 risk factors (Table 1); 5. Willing to participate with informed consent signed.

Exclusion criteria

Exclusion criteria: 1. Secondary hypertension; 2. Blood pressure = 180/110 mmHg; 3. History of cerebrovascular events: Ischemic stroke, cerebral hemorrhage, transient ischemic attack; 4. Coronary heart disease: Prior myocardial infarction, history of angina, myocardial revascularization with PCI or CABG; 5. Pulse pressure = 60mmHg (in the elderly); 6. Echocardiographic LVH: men > 115g/m2, women > 95 g/m2; 7. Carotid wall thickeningL IMT > 0.9mm or plaque; 8. Arterial stiffness; 9. Ankle-brachial index 30 mg/24 h, or albumin–creatinine ratio 30-300mg/g; 14. Advanced retinopathy: haemorrhages or exudates, papilloedema; 15. Pregnant or with pregnancy plan; 16. Cancer; 17. Severely hepatic dysfunction; 18. Mental sickness without civil capacity; 19. Contraindications for irbesartan, amlodipine, and hydrochlorothiazide; 20. Under treatment of medications interfering BP, e.g. corticosteroid, contraceptive, et al; 21. Unable to be followed-up; 22. Other situations not appropriate for study.

Design outcomes

Primary

MeasureTime frame
Bood pressure reduction;

Secondary

MeasureTime frame
Blood pressure control rate;Adverse event;

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