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Not Yet Recruiting NCT05605418

Study of a Comprehensive Intelligent Hypertension managEment SyStem

Conditions: Hypertension

Sex: All
Ages: 35 Years – 79 Years
Phase: NA
Enrollment: 1600
Sponsor: China National Center for Cardiovascular Diseases

Location: China

Summary

This cluster randomized controlled trial aims to evaluate the efficacy of a comprehensive intelligent hypertension management system (CHESS) in blood pressure lowering in primary health care (PHC) settings of China.

Eligibility Criteria

Inclusion Criteria for Sites: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;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)Has an outpatient clinic for hypertension treatment and staff are willing to take part in the study.Inclusion Criteria for Participants:Age ≥35 years and <80 yearsLocal 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;Established diagnosis of essential hypertension, with uncontrolled BP before randomization (defined as office BP≥140/90mmHg, and 24-hour ambulatory BP≥130/80mmHg);Own and be able to use a smartphone daily;Be willing to participate in the study and sign the informed consent.Exclusion Criteria for participants: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;Office or ambulatory SBP≥180 mmHg and/or DBP≥110 mmHg before randomization;Physician-diagnosed atrial fibrillation;Physician-diagnosed CKD, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (if serum creatinine is available), or currently on dialysis treatment;Physician-diagnosed hepatic dysfunction, or ALT≥ 2*ULN;Currently at the unstable or terminal stage of any disease (e.g. new- onset cardiovascular and cerebrovascular diseases occurred within 3 months, malignant tumors);Intolerance to at least two classes of antihypertensive medications among A, B, C or D;Currently taking 3 or more antihypertensive drugs;The subject is pregnant or breastfeeding, or planning to become pregnant or breastfeeding during the study period;Have communication or cognitive disorders;Be unwilling to take antihypertensive drugs, or assumed poor adherence to treatment;The subject is participating in other clinical trials at the moment.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05605418). StuddyBuddy aggregates publicly available trial information.