RecruitingRecruiting
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
NCT06828692 · China National Center for Cardiovascular Diseases
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Eligibility criteria
Inclusion Criteria:
1. 35 ≤ Age \< 80 years.
2. Regularly attend the clinic for hypertension treatment during the study period, without plans of traveling during the study period.
3. Diagnosed with hypertension, with SBP ≥140mmHg at screening.
4. Currently taking 0 or 2 classes of antihypertensive medications (A/C/D), with or without concurrent use of class B.
5. Willing to participate in the trial and capable of providing written informed consent.
Exclusion Criteria:
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).
2. SBP ≥180mmHg and/or DBP ≥110mmHg at the screening visit.
3. Suspected or diagnosed white coat hypertension.
4. History of coronary heart disease.
5. History of heart failure.
6. Intolerance to 2 or more classes of A, C,D antihypertensive medications.
7. Currently taking antihypertensive medications other than class A,B,C and D.
8. Diagnosed chronic kidney disease, estimating Glomerular Filtration Rate (eGFR)\< 60 ml/min·1.73m2, or receiving dialysis.
9. Serious medical conditions (e.g., malignant cancer and hepatic dysfunction)
10. Currently in an acute episode of disease (e.g, new-onset cardiovascular and cerebrovascular disease occurred within 3 months).
11. Cognitive or communicative disorders.
12. Currently pregnant or breastfeeding or planning a pregnant or breastfeeding during the study.
13. Reluctant to take antihypertensive medications or have poor compliance with previous treatment.
14. Participating in other clinical trials.
Study design
Enrollment target: 2160 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-05-26
Estimated completion: 2026-05-31
Last updated: 2026-02-12
Interventions
Combination Product: Group A (clinical guideline+machine learning)Combination Product: Group B (clinical guideline+impedance cardiograph+machine learning)Other: Group C (usual care)
Primary outcomes
- • hierarchical composite outcome (Baseline; 3 months)
Sponsor
China National Center for Cardiovascular Diseases · other_gov
Contacts & investigators
ContactXiaofang Yan · contact · yanxiaofang@fuwai.com · 0086 10 60686871
ContactXin Zheng · contact · zhengxin@fuwai.com · 0086 10 60866719
InvestigatorXin Zheng · principal_investigator, Fuwai Hospital, China Academy of Medical Sciences, National Center for Cardiovascular Diseases
All locations (1)
Fuwai Shenzhen Hospital, Chinese Academy of Medical SciencesRecruiting
Shenzhen, Shenzhen, China