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NCT Number: 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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

35 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Shenzhen Hospital, Chinese Academy of Medical Sciences

Shenzhen, China

Location status: Recruiting

Location contact

Xiaofang Yan

CONTACT

[email protected]

0086 1358186128

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group A (clinical guideline+machine learning)

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 (clinical guideline+impedance cardiograph+machine learning)

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 (usual care)

Other

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

Primary outcomes

  1. hierarchical composite outcome

    Time frame: Baseline; 3 months

    The primary outcome of the trial is a hierarchical composite outcome, evaluated using the Win-ratio method in the following order:

    • Office blood pressure control rate (<130/80 mmHg) at 3 months after randomization.
    • The duration from baseline to the first occurrence of controlled blood pressure achievement (<130/80 mmHg) within 3 months after randomization.
    • The composite index of the number and dosage of antihypertensive drugs among participants achieved controlled blood pressure at 3 months after randomization.

Secondary outcomes

  1. Separate evaluation of each component of the three-tier hierarchical composite primary outcome at 3 months

    Time frame: Baseline; 3 months

  2. Changes in office systolic and diastolic blood pressure from baseline to 1 month and 3 months

    Time frame: Baseline; 1 month; 3 months

  3. Average 24-hour ambulatory systolic and diastolic blood pressure, along with blood pressure control rate at 3 months

    Time frame: 3 months

  4. Changes in hemodynamic parameters measured by ICG from baseline to 3 months

    Time frame: Baseline; 3 months

    Including dynamic parameters (heart rate and cardiac index), resistance parameters (arterial stiffness index and systemic vascular resistance index), and volume parameters (thoracic blood volume saturation)

  5. 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

Other outcomes

  1. safety outcome

    Time frame: Baseline; 3 months

    Safety outcomes include serious adverse events, non-serious adverse events, such as symptomatic hypotension or SBP <90 mmHg, injury falls, syncope, and bradycardia (heart rate <50 beats/minute) during study periods.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaofang Yan

CONTACT

[email protected]

0086 10 60686871

Xin Zheng

CONTACT

[email protected]

0086 10 60866719

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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