Randomized Study of Antihypertensive Intervention by Intelligent Hypertension Management System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive Patients
- Sponsor
- Shanghai Tong Ren Hospital
- Enrollment
- 320
- Locations
- 3
- Primary Endpoint
- Net change in systolic blood pressure from baseline to 3 months follow-up
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
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)
Investigators
Hou Lei
Director of cardiovascular disease institute
Shanghai Tong Ren Hospital
Eligibility Criteria
Inclusion Criteria
- •Aged more than 18 years old, less than or equal to 75 years old.
- •Hypertensive patients (systolic/diastolic blood pressure ≥140/90 mmHg at two separate screening/baseline visits)
- •Patients or guardians can skillfully use devices such as smartphones and electronic sphygmomanometers
- •Voluntarily joined and signed the informed consent
Exclusion Criteria
- •Pregnant women or women planning to become pregnant within the next year;
- •Patients with secondary hypertension
- •Patients with life expectancy less than 1 year
- •Severe hepatic and renal insufficiency (ALT \> 5 times ULA, eGFR \< 15ml/min/1.73mm2)
- •Known active malignancy disease
- •The researcher believes that patients who are not suitable to participate in this study
Outcomes
Primary Outcomes
Net change in systolic blood pressure from baseline to 3 months follow-up
Time Frame: one and three months after study
Secondary Outcomes
- Net change in diastolic blood pressure(one and three months after study)
- Hypertension control ratio (BP < 140/90 mmHg)(one and three months after study)