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Intelligent Hypertension Intervention Study

Randomized Study of Antihypertensive Intervention by Intelligent Hypertension Management System

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05526300
Enrollment
320
Registered
2022-09-02
Start date
2022-09-06
Completion date
2024-12-01
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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)

Interventions

DEVICEIntelligent Hypertension Management System

The intelligent hypertension management system is used to remotely detect the blood pressure of hypertensive patients

OTHERThe standard care

The standard care

Sponsors

Shanghai Tong Ren Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Net change in systolic blood pressure from baseline to 3 months follow-upone and three months after study

Secondary

MeasureTime frame
Net change in diastolic blood pressureone and three months after study
Hypertension control ratio (BP < 140/90 mmHg)one and three months after study

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026