HypertensionNCT06828692
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
A study testing Group A (clinical guideline+machine learning) and Group B (clinical guideline+impedance cardiograph+machine learning) in people with Hypertension, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 79 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Group A (clinical guideline+machine learning) and Group B (clinical guideline+impedance cardiograph+machine learning)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,160 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Shenzhen Hospital, Chinese Academy of Medical Sciences
Shenzhen, Shenzhen
Xiaofang Yan, 0086 1358186128, yanxiaofang@fuwai.com
About this study
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.
- Conditions
- Hypertension
- Being tested
- Group A (clinical guideline+machine learning), Group B (clinical guideline+impedance cardiograph+machine learning), Group C (usual care)
- Keywords
- Hypertension, CDSS, cluster randomized controlled trial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (CG+ML) | Experimental | Not described Receives: Combination Product: Group A (clinical guideline+machine learning) |
| Group B (CG+ICG+ML) | Experimental | Not described Receives: Combination Product: Group B (clinical guideline+impedance cardiograph+machine learning) |
| Group C (UC) | Other | Not described Receives: Other: Group C (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
hierarchical composite outcome
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.
Measured: Baseline; 3 months
Secondary outcomes (5)
Separate evaluation of each component of the three-tier hierarchical composite primary outcome at 3 months
Measured: Baseline; 3 months
Changes in office systolic and diastolic blood pressure from baseline to 1 month and 3 months
Measured: Baseline; 1 month; 3 months
Average 24-hour ambulatory systolic and diastolic blood pressure, along with blood pressure control rate at 3 months
Measured: 3 months
Changes in hemodynamic parameters measured by ICG from baseline to 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)
Measured: 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
Measured: Baseline; 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start26 May 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xin Zheng, Principal investigator, Fuwai Hospital, China Academy of Medical Sciences, National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828692
- Sponsor's protocol ID
- NCRCSZ-2023-014
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06828692
- Acronym / sponsor ID
- NCRCSZ-2023-014
- Conditions
- Hypertension
- Keywords
- Hypertension, CDSS, cluster randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,160 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 26 May 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (CG+ML) | Experimental | Combination Product: Group A (clinical guideline+machine learning) |
| Group B (CG+ICG+ML) | Experimental | Combination Product: Group B (clinical guideline+impedance cardiograph+machine learning) |
| Group C (UC) | Other | Other: Group C (usual care) |
Who may qualify
- Ages
- 35 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 A (CG+ML) |
| 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. | Combination product | Group B (CG+ICG+ML) |
| Group C (usual care)Control group, the physicians manage the hypertensive patients according to their knowledge and experiences. | Other | Group C (UC) |
Primary outcome
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: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
Related trials for Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Not yet recruitingPhase 4
A Clinical Study of MK-7962 in Chinese Participants With Pulmonary Arterial Hypertension (MK-7962-022)
Hypertension, Pulmonary
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Not yet recruitingObservational study
Real-World Validation for Less-Disturbing Ambulatory Blood Pressure Monitoring (ABPM) in Malaysia Using Huawei Wearables
Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xin Zheng principal investigator
Fuwai Hospital, China Academy of Medical Sciences, National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A (clinical guideline+machine learning) and Group B (clinical guideline+impedance cardiograph+machine learning) in people with Hypertension, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaofang Yan (0086 10 60686871, yanxiaofang@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hierarchical composite outcome (time frame: Baseline; 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.