Intelligent Hypertension Intervention Study
Randomized Study of Antihypertensive Intervention by Intelligent Hypertension Management System
1 other identifier
interventional
320
1 country
3
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2022
CompletedFirst Posted
Study publicly available on registry
September 2, 2022
CompletedStudy Start
First participant enrolled
September 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMay 21, 2025
December 1, 2024
2.2 years
August 31, 2022
May 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Net change in systolic blood pressure from baseline to 3 months follow-up
one and three months after study
Secondary Outcomes (2)
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
Study Arms (2)
The standard care group
ACTIVE COMPARATORIntelligent intervention group
EXPERIMENTALInterventions
The intelligent hypertension management system is used to remotely detect the blood pressure of hypertensive patients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Shanghai tongren hospital
Shanghai, Shanghai Municipality, 200050, China
Shanghai Fifth Rehabilitation Hospital
Shanghai, China
Songjiang hospital, Shanghai jiaotong University, School of medicine
Shanghai, China
Related Publications (1)
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.
PMID: 38086588DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of cardiovascular disease institute
Study Record Dates
First Submitted
August 31, 2022
First Posted
September 2, 2022
Study Start
September 6, 2022
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
May 21, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The data will become available Immediately following publication and with no end date. T
- Access Criteria
- The data will be shared with researchers who wish to access the data to help patients for non-profit purposes.
The data that support the findings of this study are available in ClinicalTrials. gov at https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000CFXV\&selectaction=Edit\&uid=U0004XRB\&ts=32\&cx=-oc8exc. And can be accessed with reference number: NCT05526300. The individual deidentified participant data (including data dictionaries) will be available. All of the individual participant data collected during the trial will be shared after de-identification. The study protocol, and statistical analysis plan will be available. The data will become available Immediately following publication and with no end date. The data will be shared with researchers who wish to access the data to help patients for non-profit purposes. Data are available indefinitely at ClinicalTrials. gov.