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

National Center for Cardiovascular Diseases

Status: Not yet enrolling

Conditions: Hypertension

Treatments: Combination Product: Group B (clinical guideline+impedance cardiograph+machine learning); Combination Product: Group A (clinical guideline+machine learning); Other: Group C (usual care)

Study type: Interventional

Funder types: Other

Identifiers

NCT06828692

NCRCSZ-2023-014

Details and patient eligibility

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 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.

Enrollment: 2,160 estimated patients

Sex: All

Ages: 35 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,160 participants in 3 patient groups

Group A (CG+ML)

Experimental group

Treatment:

Combination Product: Group A (clinical guideline+machine learning)

Group B (CG+ICG+ML)

Experimental group

Treatment:

Combination Product: Group B (clinical guideline+impedance cardiograph+machine learning)

Group C (UC)

Other group

Treatment:

Other: Group C (usual care)