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New treatment option for Hypertension
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
What this study is testing
What is Group A (clinical guideline+machine learning)?
Group A (clinical guideline+machine learning) is an investigational medicine, being studied as a potential treatment for hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 79
You may be able to join if
- 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.
You likely can't join if
- Physician-diagnosed or suspected secondary hypertension (e.g., hypertension caused by renal disease, renal artery stenosis, aortic stenosis, primary...
- 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.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Shenzhen, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Shenzhen, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.