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NCT07917676Not yet recruiting

Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk

Effects of Multimodal Artificial Intelligence-Driven Out-of-Hospital Management on Patients With Hypertension and Cardiometabolic Risk Factors

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

High blood pressure often occurs together with abnormal blood glucose, abnormal blood lipids, or abdominal obesity. Managing these conditions outside the hospital can be difficult. This study will test whether a digital health program that combines artificial intelligence (AI) with review and support by doctors and nurses improves health outcomes compared with standard out-of-hospital guidance. The study will enroll 150 adults aged 18 to 70 years who have hypertension and at least one additional cardiometabolic risk factor that is not at target. Participants will be randomly assigned in a 1:1 ratio to either the hybrid AI-assisted management group or the standard-guidance group. The intervention group will use a patient mini-program and connected devices to monitor blood pressure, glucose, and lifestyle information. The AI system will propose personalized medication, diet, exercise, and monitoring plans, which the healthcare team will review and confirm before delivery. The control group will receive routine printed health education and usual clinical follow-up. All participants will be followed for 6 months. The main outcome is the proportion of participants achieving blood pressure control together with control of at least one glycemic or lipid indicator. Other assessments include treatment adherence, cardiovascular events, hospitalizations, medical costs, quality of life, and system usability.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
150 (estimated)
First submitted
30 Oct 2026
Start date
3 Nov 2026
Primary completion date
31 Dec 2027
Lead sponsor
China National Center for Cardiovascular Diseases
NCT number
NCT07917676

What you commit to

  • Study type: Interventional
  • Planned participants: 150
  • From 3 Nov 2026 to the primary completion date, 31 Dec 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Secondary hypertension, acute hypertension, subacute hypertension, or hypertensive encephalopathy.
  • Severe primary hypertension (SBP ≥180 mmHg and/or DBP ≥110 mmHg) or poorly controlled primary hypertension.
  • Acute myocardial infarction, unstable angina, or coronary revascularization (PCI or CABG) within 6 months.
  • Cerebral infarction or cerebral hemorrhage within 6 months.
  • Severe heart failure (NYHA class III-IV).
  • Uncontrolled severe arrhythmia, such as symptomatic ventricular tachycardia or high-grade atrioventricular block.
  • Chronic kidney disease.
  • Severe psychiatric illness preventing cooperation.
  • Other severe conditions preventing digital management, including severe visual/hearing impairment or cognitive dysfunction.
  • Any other condition considered by the investigator to make participation unsuitable.

Lab values

  • ALT or AST ≥3 × ULN; for patients receiving lipid-lowering therapy, ALT or AST ≥2 × ULN that does not normalize after drug discontinuation.

Other

  • Life expectancy \<12 months.
  • Participation in another clinical study within 3 months.
  • Refusal to sign informed consent.

Who the study is looking for

  • Aged 18-70 years.
  • Confirmed hypertension plus at least one of dyslipidemia, hyperglycemia, or abdominal obesity, with at least one condition not at target. Hypertension: BP ≥130/85 mmHg and/or diagnosed hypertension under treatment. Hyperglycemia: fasting glucose ≥6.1 mmol/L or 2-hour post-load glucose ≥7.8 mmol/L and/or diagnosed diabetes under treatment. Abdominal obesity: waist circumference ≥90 cm in men or ≥85 cm in women. Dyslipidemia: fasting triglycerides ≥1.7 mmol/L, LDL-C ≥4.1 mmol/L in the general population, or failure to meet the ASCVD risk-stratified LDL-C target (\<2.6 mmol/L for general low-risk adults; \<1.8 mmol/L for specified higher-risk groups; \<1.4 mmol/L for specified very-high-risk ASCVD groups).
  • Able to use a smartphone and smart wearable devices.
  • Relatively stable work/life circumstances and residence for the next 6 months.
  • Voluntary participation and signed informed consent.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.