CompletedNot Applicable

Study of a Comprehensive Intelligent Hypertension managEment SyStem

China1,666 participantsStarted 2023-03-16

Plain-language 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.

Who can participate

Age range35 Years – 79 Years

SexALL

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Inclusion criteria

✓. 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:
✓. Has an outpatient clinic for hypertension treatment and staff are willing to take part in the study.
✓. Age ≥35 years and \<80 years
✓. 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;
✓. 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

✕. 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;

What they're measuring

Mean change in 24-hour ambulatory SBP from baseline to 12-month follow up;

Timeframe: Baseline; 12 months

Trial details

NCT IDNCT05605418

SponsorChina National Center for Cardiovascular Diseases

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-10-30

View on ClinicalTrials.gov More Hypertension trials