Intelligent Hypertension Intervention Study

Not Applicable

Completed

• Conditions: To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive Patients
• Interventions: Other: The standard care; Device: Intelligent Hypertension Management System

• Registration Number: NCT05526300
• Lead Sponsor: Shanghai Tong Ren Hospital

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-02
• Study Start: 2022-09-06
• Status Verified: 2024-12
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The standard care group	The standard care	-
Intelligent intervention group	Intelligent Hypertension Management System	-

Primary Outcome Measures

Name	Time	Method
Net change in systolic blood pressure from baseline to 3 months follow-up	one and three months after study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Shanghai tongren hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Fifth Rehabilitation Hospital; 🇨🇳 Shanghai, China

Songjiang hospital, Shanghai jiaotong University, School of medicine; 🇨🇳 Shanghai, China