Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT05605418
Eligibility Criteria:
Inclusion Criteria for Sites:
1. An electronic data collection system is routinely used at the clinic for hypertension management in PHC sites, and the distance between sites must be \>2km;
2. At least one drug of each of the five classes of recommended antihypertensive medications is available at the clinic:
* A: Angiotensin-converting enzyme inhibitors (ACEI; e.g., captopril or enalapril);
* A: Angiotensin receptor blockers (ARB; e.g., losartan or valsartan)
* B: β-blockers (e.g., atenolol, metoprolol, or bisoprolol)
* C: Calcium antagonists (e.g., nitrendipine, nifedipine, or amlodipine)
* D: Diuretics (e.g., hydrochlorothiazide, indapamide, or indapamide SR tablets)
3. Has an outpatient clinic for hypertension treatment and staff are willing to take part in the study.
Inclusion Criteria for Participants:
1. Age ≥35 years and \<80 years
2. Local resident of the community/township who attends the PHC clinic for hypertension management, and will not travel for more than 3 months during the study period;
3. Established diagnosis of essential hypertension, with uncontrolled BP before randomization (defined as office BP≥140/90mmHg, and 24-hour ambulatory BP≥130/80mmHg);
4. Own and be able to use a smartphone daily;
5. Be willing to participate in the study and sign the informed consent.
Exclusion Criteria for participants:
1. Physician-diagnosed or suspected secondary hypertension (e.g. hypertension caused by renal disease, renal artery stenosis, aortic stenosis, primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid dysfunction, intracranial disease, drug- induced, or rare monogenic genetic disease), or the presence of other structural heart diseases, such as aortic insufficiency, hypertrophic cardiomyopathy, or congenital heart disease;
2. Office or ambulatory SBP≥180 mmHg and/or DBP≥110 mmHg before randomization;
3. Physician-diagnosed atrial fibrillation;
4. Physician-diagnosed CKD, estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 (if serum creatinine is available), or currently on dialysis treatment;
5. Physician-diagnosed hepatic dysfunction, or ALT≥ 2\*ULN;
6. Currently at the unstable or terminal stage of any disease (e.g. new- onset cardiovascular and cerebrovascular diseases occurred within 3 months, malignant tumors);
7. Intolerance to at least two classes of antihypertensive medications among A, B, C or D;
8. Currently taking 3 or more antihypertensive drugs;
9. The subject is pregnant or breastfeeding, or planning to become pregnant or breastfeeding during the study period;
10. Have communication or cognitive disorders;
11. Be unwilling to take antihypertensive drugs, or assumed poor adherence to treatment;
12. The subject is participating in other clinical trials at the moment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
79 Years
Study:
NCT05605418
Study Brief:
Protocol Section:
NCT05605418