Actively Recruiting
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
Led by China National Center for Cardiovascular Diseases · Updated on 2026-02-12
2160
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 35 and less than 80 years
- Regularly attend the clinic for hypertension treatment during the study period without plans to travel
- Diagnosed with hypertension with systolic blood pressure (SBP) 140 mmHg or higher at screening
- Currently taking zero or up to two classes of antihypertensive medications (A/C/D), with or without concurrent use of class B
- Willing to participate and able to provide written informed consent
You will not qualify if you...
- Diagnosed or suspected secondary hypertension due to specific medical conditions
- Systolic blood pressure 180 mmHg or higher and/or diastolic blood pressure 110 mmHg or higher at screening
- Suspected or diagnosed white coat hypertension
- History of coronary heart disease
- History of heart failure
- Intolerance to two or more classes of A, C, D antihypertensive medications
- Currently taking antihypertensive medications other than classes A, B, C, or D
- Diagnosed chronic kidney disease with eGFR less than 60 ml/min/1.73m2 or on dialysis
- Serious medical conditions such as malignant cancer or liver dysfunction
- Currently in an acute episode of disease within the last 3 months
- Cognitive or communicative disorders
- Currently pregnant, breastfeeding, or planning pregnancy or breastfeeding during the study
- Reluctant to take antihypertensive medications or poor compliance with previous treatment
- Participating in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fuwai Shenzhen Hospital, Chinese Academy of Medical Sciences
Shenzhen, Shenzhen, China
Actively Recruiting
Research Team
X
Xiaofang Yan
CONTACT
X
Xin Zheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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