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Recruiting 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

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group A (clinical guideline+machine learning), Group B (clinical guideline+impedance cardiograph+machine learning), Group C (usual care).
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: 35 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Combination product 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.
  • 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.
  • Other Group C (usual care)
    Control group, the physicians manage the hypertensive patients according to their knowledge and experiences.

Primary outcome measures

  • hierarchical composite outcome [Time frame: Baseline; 3 months]
Secondary outcome measures (5)
  • Separate evaluation of each component of the three-tier hierarchical composite primary outcome at 3 months [Time frame: Baseline; 3 months]
  • Changes in office systolic and diastolic blood pressure from baseline to 1 month and 3 months [Time frame: Baseline; 1 month; 3 months]
  • Average 24-hour ambulatory systolic and diastolic blood pressure, along with blood pressure control rate at 3 months [Time frame: 3 months]
  • Changes in hemodynamic parameters measured by ICG from baseline to 3 months [Time frame: Baseline; 3 months]
  • 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 [Time frame: Baseline; 3 months]

Eligibility criteria

Inclusion criteria

  • 35 ≤ Age < 80 years.
  • Regularly attend the clinic for hypertension treatment during the study period, without plans of traveling during the study period.
  • Diagnosed with hypertension, with SBP ≥140mmHg at screening.
  • Currently taking 0 or 2 classes of antihypertensive medications (A/C/D), with or without concurrent use of class B.
  • Willing to participate in the trial and capable of providing written informed consent.

Exclusion criteria

  • 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).
  • SBP ≥180mmHg and/or DBP ≥110mmHg at the screening visit.
  • Suspected or diagnosed white coat hypertension.
  • History of coronary heart disease.
  • History of heart failure.
  • Intolerance to 2 or more classes of A, C,D antihypertensive medications.
  • Currently taking antihypertensive medications other than class A,B,C and D.
  • Diagnosed chronic kidney disease, estimating Glomerular Filtration Rate (eGFR)< 60 ml/min·1.73m2, or receiving dialysis.
  • Serious medical conditions (e.g., malignant cancer and hepatic dysfunction)
  • Currently in an acute episode of disease (e.g, new-onset cardiovascular and cerebrovascular disease occurred within 3 months).
  • Cognitive or communicative disorders.
  • Currently pregnant or breastfeeding or planning a pregnant or breastfeeding during the study.
  • Reluctant to take antihypertensive medications or have poor compliance with previous treatment.
  • Participating in other clinical trials.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Fuwai Shenzhen Hospital, Chinese Academy of Medical Sciences — Shenzhen

Identifiers

NCT: NCT06828692 · NCRCSZ-2023-014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗