Hypertension
Conditions
Keywords
Hypertension, CDSS, cluster randomized controlled trial
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 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_PRODUCTGroup 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_PRODUCTGroup 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.
OTHERGroup C (usual care)
Control group, the physicians manage the hypertensive patients according to their knowledge and experiences.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hierarchical composite outcome | Baseline; 3 months | The primary outcome of the trial is a hierarchical composite outcome, evaluated using the Win-ratio method in the following order: 1. Office blood pressure control rate (\<130/80 mmHg) at 3 months after randomization. 2. The duration from baseline to the first occurrence of controlled blood pressure achievement (\<130/80 mmHg) within 3 months after randomization. 3. The composite index of the number and dosage of antihypertensive drugs among participants achieved controlled blood pressure at 3 months after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Separate evaluation of each component of the three-tier hierarchical composite primary outcome at 3 months | Baseline; 3 months | — |
| Changes in office systolic and diastolic blood pressure from baseline to 1 month and 3 months | Baseline; 1 month; 3 months | — |
| Average 24-hour ambulatory systolic and diastolic blood pressure, along with blood pressure control rate at 3 months | 3 months | — |
| Changes in hemodynamic parameters measured by ICG from baseline to 3 months | 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) |
| 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 | Baseline; 3 months | — |
Countries
China
Contacts
CONTACTXiaofang Yan
CONTACTXin Zheng
PRINCIPAL_INVESTIGATORXin Zheng
Fuwai Hospital, China Academy of Medical Sciences, National Center for Cardiovascular Diseases
Outcome results
None listed