Intelligent Hypertension Intervention Study

Shanghai Jiao Tong University

Status: Completed

Conditions: To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive Patients

Treatments: Other: The standard care; Device: Intelligent Hypertension Management System

Study type: Interventional

Funder types: Other

Identifiers

NCT05526300

ShanghaiTRH-hypertension

Details and patient eligibility

About

To explore whether the application of intelligent hypertension management system can effectively reduce blood pressure in hypertensive patients. A total of 320 eligible subjects will be recruited and randomization to two groups. The standard care group (n=160) will receive conventional hypertension treatment with baseline data collected.Wearable blood pressure monitoring device management group (intervention group, n=160) will receive blood pressure monitoring remotely everyday and antihypertension medication treatment. Primary outcome is Net change in systolic blood pressure from baseline to 3 months follow-up. Secondary outcomes include Net change in diastolic blood pressure hypertension control ratio (BP < 140/90 mmHg)

Enrollment: 320 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged more than 18 years old, less than or equal to 75 years old.
2. Hypertensive patients (systolic/diastolic blood pressure ≥140/90 mmHg at two separate screening/baseline visits)
3. Patients or guardians can skillfully use devices such as smartphones and electronic sphygmomanometers
4. Voluntarily joined and signed the informed consent

Exclusion criteria

1. Pregnant women or women planning to become pregnant within the next year;
2. Patients with secondary hypertension
3. Patients with life expectancy less than 1 year
4. Severe hepatic and renal insufficiency (ALT > 5 times ULA, eGFR < 15ml/min/1.73mm2)
5. Known active malignancy disease
6. The researcher believes that patients who are not suitable to participate in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

The standard care group

Active Comparator group

Treatment:

Other: The standard care

Intelligent intervention group

Experimental group

Treatment:

Device: Intelligent Hypertension Management System