NCT06828692 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
| NCT ID | NCT06828692 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,160 participants |
| Start Date | 2025-05-26 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,160 participants in total. It began in 2025-05-26 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Contact & Investigator
Xin Zheng
PRINCIPAL INVESTIGATOR
Fuwai Hospital, China Academy of Medical Sciences, National Center for Cardiovascular Diseases
Frequently Asked Questions
Who can join the NCT06828692 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 79 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06828692 currently recruiting?
Yes, NCT06828692 is actively recruiting participants. Contact the research team at yanxiaofang@fuwai.com for enrollment information.
Where is the NCT06828692 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT06828692 clinical trial?
NCT06828692 is sponsored by China National Center for Cardiovascular Diseases. The principal investigator is Xin Zheng at Fuwai Hospital, China Academy of Medical Sciences, National Center for Cardiovascular Diseases. The trial plans to enroll 2,160 participants.