Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
CDSS
cluster randomized controlled trial
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2025-02-14
Enrollment: 2160
Sex: ALL
Minimum age (years): 35
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: hierarchical composite outcome
timeFrame: Baseline; 3 months
Secondary outcomes:
measure: Separate evaluation of each component of the three-tier hierarchical composite primary outcome at 3 months
timeFrame: Baseline; 3 months
measure: Changes in office systolic and diastolic blood pressure from baseline to 1 month and 3 months
timeFrame: Baseline; 1 month; 3 months
measure: Average 24-hour ambulatory systolic and diastolic blood pressure, along with blood pressure control rate at 3 months
timeFrame: 3 months
measure: Changes in hemodynamic parameters measured by ICG from baseline to 3 months
timeFrame: Baseline; 3 months
measure: Differences in the three-tier hierarchical composite primary outcomes and each component of the three-tier hierarchical composite primary outcome among intervention groups at 3 months
timeFrame: Baseline; 3 months
Other outcomes:
measure: safety outcome
timeFrame: Baseline; 3 months
Locations:
Study officials:
affiliation: Fuwai Hospital, China Academy of Medical Sciences, National Center for Cardiovascular Diseases
name: Xin Zheng
role: PRINCIPAL_INVESTIGATOR
References: