NCT07917676Toborzás még nem indult
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 4.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 150 (tervezett)
- Első benyújtás
- 2026. okt. 30.
- Kezdés
- 2026. nov. 3.
- Elsődleges befejezés
- 2027. dec. 31.
- Fő szponzor
- China National Center for Cardiovascular Diseases
- Betegségek
- Magas vérnyomás
- NCT-szám
- NCT07917676
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 150
- 2026. nov. 3. és az elsődleges befejezés (2027. dec. 31.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Más betegség
- 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.
Laborértékek
- ALT or AST ≥3 × ULN; for patients receiving lipid-lowering therapy, ALT or AST ≥2 × ULN that does not normalize after drug discontinuation.
Egyéb
- Life expectancy <12 months.
- Participation in another clinical study within 3 months.
- Refusal to sign informed consent.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.