NCT06828692Completed
Implementation of Machine Learning and Hemodynamic Profiles Based Clinical Decision Support Systems for Personalized Guideline Accordant Antihypertensive Regimens in Primary Care: a Pragmatic Cluster Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
This trial is a prospective, multicenter, single-blind, three-arm parallel-group, cluster randomized controlled trial assessing the effectiveness and safety of two types of CDSS in primary care settings in China. Primary care sites are randomized to one of the intervention arms or the control arm (1:1:1 ratio) using computer-generated random numbers stratified by region and administrative categories of the primary healthcare institutions (including community health centers, community health stations, and township health centers). A total of 51 primary care sites are randomized to three groups, with 17 sites assigned to group A (use a CDSS based on clinical guidelines and machine learning), 17 sites to group B (use a CDSS based on guidelines, hemodynamic parameters and ML), and the remaining 17 sites to the control group.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1946 (actual)
- First submitted
- 6 Feb 2025
- Start date
- 26 May 2025
- Primary completion date
- 9 Mar 2026
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- High blood pressure
- NCT number
- NCT06828692
What you commit to
- Study type: Interventional
- Participants enrolled: 1946
- From 26 May 2025 to the primary completion date, 9 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intolerance to 2 or more classes of A, C,D antihypertensive medications.
- Currently taking antihypertensive medications other than class A,B,C and D.
- Reluctant to take antihypertensive medications or have poor compliance with previous treatment.
Other illness
- 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).
- Suspected or diagnosed white coat hypertension.
- History of coronary heart disease.
- History of heart failure.
- Serious medical conditions (e.g., malignant cancer and hepatic dysfunction)
- Currently in an acute episode of disease (e.g, new-onset cardiovascular and cerebrovascular disease occurred within 3 months).
- Cognitive or communicative disorders.
Lab values
- Diagnosed chronic kidney disease, estimating Glomerular Filtration Rate (eGFR)\< 60 ml/min·1.73m2, or receiving dialysis.
Other
- SBP ≥180mmHg and/or DBP ≥110mmHg at the screening visit.
- Currently pregnant or breastfeeding or planning a pregnant or breastfeeding during the study.
- Participating in other clinical trials.
Who the study is looking for
- 35 ≤ Age \< 80 years.
- Regularly attend the clinic for hypertension treatment during the study period, without plans of traveling during the study period.
- Diagnosed with hypertension, with SBP ≥140mmHg at screening.
- Currently taking 0 or 2 classes of antihypertensive medications (A/C/D), with or without concurrent use of class B.
- Willing to participate in the trial and capable of providing written informed consent.
Age in the registry: 35 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Shenzhen Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.