Intelligent Hypertension Intervention Study

Randomized Study of Antihypertensive Intervention by Intelligent Hypertension Management System

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)

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Fifth Rehabilitation Hospital
  • Shanghai, China
    • Songjiang hospital, Shanghai jiaotong University, School of medicine
  • Shanghai
    • Shanghai, Shanghai, China, 200050
      • Shanghai Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The standard care group	Other: The standard care; The standard care
Experimental: Intelligent intervention group	Device: Intelligent Hypertension Management System; The intelligent hypertension management system is used to remotely detect the blood pressure of hypertensive patients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Tong Ren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: ShanghaiTRH-hypertension

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will become available Immediately following publication and with no end date. T
• IPD Sharing Access Criteria: The data will be shared with researchers who wish to access the data to help patients for non-profit purposes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No