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

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2025-12-31

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 45 primary care sites are randomized to three groups, with 15 sites assigned to group A (use a CDSS based on clinical guidelines and machine learning), 15 sites to group B (use a CDSS based on guidelines, hemodynamic parameters and ML), and the remaining 15 sites to the control group.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A (CG+ML)

Group Type: EXPERIMENTAL

Group A (clinical guideline+machine learning)

Intervention Type: COMBINATION_PRODUCT

Group A (CG+ML): A Clinical Decision Support System (CDSS) with the algorithm that incorporates clinical guideline (CG) and machine learning (ML) approach.

Group B (CG+ICG+ML)

Group Type: EXPERIMENTAL

Group B (clinical guideline+impedance cardiograph+machine learning)

Intervention Type: COMBINATION_PRODUCT

Group B (CG+ICG+ML): A Clinical Decision Support System (CDSS) with the algorithm that incorporates clinical guideline (CG), hemodynamic parameters measured by impedance cardiograph (ICG), and machine learning (ML) approach.

Group C (UC)

Group Type: OTHER

Group C (usual care)

Intervention Type: OTHER

Control group, the physicians manage the hypertensive patients according to their knowledge and experiences.

Interventions

Group A (clinical guideline+machine learning)

Group A (CG+ML): A Clinical Decision Support System (CDSS) with the algorithm that incorporates clinical guideline (CG) and machine learning (ML) approach.

Intervention Type: COMBINATION_PRODUCT

Group B (clinical guideline+impedance cardiograph+machine learning)

Group B (CG+ICG+ML): A Clinical Decision Support System (CDSS) with the algorithm that incorporates clinical guideline (CG), hemodynamic parameters measured by impedance cardiograph (ICG), and machine learning (ML) approach.

Intervention Type: COMBINATION_PRODUCT

Group C (usual care)

Control group, the physicians manage the hypertensive patients according to their knowledge and experiences.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xin Zheng

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, China Academy of Medical Sciences, National Center for Cardiovascular Diseases

Central Contacts

Xiaofang Yan

Role: CONTACT

yanxiaofang@fuwai.com

0086 10 60686871

Xin Zheng

Role: CONTACT

zhengxin@fuwai.com

0086 10 60866719

Other Identifiers

NCRCSZ-2023-014

Identifier Type: -

Identifier Source: org_study_id