Intelligent Hypertension Intervention Study

NCT ID: NCT05526300

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-06

Study Completion Date

2024-12-01

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The standard care group

Group Type ACTIVE_COMPARATOR

The standard care

Intervention Type OTHER

The standard care

Intelligent intervention group

Group Type EXPERIMENTAL

Intelligent Hypertension Management System

Intervention Type DEVICE

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

Interventions

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Intelligent Hypertension Management System

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

Intervention Type DEVICE

The standard care

The standard care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Tong Ren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hou Lei

Director of cardiovascular disease institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai tongren hospital

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Fifth Rehabilitation Hospital

Shanghai, , China

Site Status

Songjiang hospital, Shanghai jiaotong University, School of medicine

Shanghai, , China

Site Status

Countries

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China

References

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Yu H, Chen X, Xia J, Hou L. Effect of intelligent hypertension management system on blood pressure: protocol for a randomised controlled multicentre trial. BMJ Open. 2023 Dec 12;13(12):e074580. doi: 10.1136/bmjopen-2023-074580.

Reference Type DERIVED
PMID: 38086588 (View on PubMed)

Other Identifiers

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ShanghaiTRH-hypertension

Identifier Type: -

Identifier Source: org_study_id

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