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Intelligent Hypertension Intervention Study

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intelligent Hypertension Management System
The standard care
Sponsored by
Shanghai Tong Ren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive Patients

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai tongren hospitalRecruiting
  • Shanghai Tongren HospitalRecruiting
  • Songjiang hospital, Shanghai jiaotong University, School of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

The standard care group

Intelligent intervention group

Arm Description

Outcomes

Primary Outcome Measures

Net change in systolic blood pressure from baseline to 3 months follow-up

Secondary Outcome Measures

Net change in diastolic blood pressure
Hypertension control ratio (BP < 140/90 mmHg)

Full Information

First Posted
August 31, 2022
Last Updated
October 4, 2023
Sponsor
Shanghai Tong Ren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05526300
Brief Title
Intelligent Hypertension Intervention Study
Official Title
Randomized Study of Antihypertensive Intervention by Intelligent Hypertension Management System
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Tong Ren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The standard care group
Arm Type
Active Comparator
Arm Title
Intelligent intervention group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Intelligent Hypertension Management System
Intervention Description
The intelligent hypertension management system is used to remotely detect the blood pressure of hypertensive patients
Intervention Type
Other
Intervention Name(s)
The standard care
Intervention Description
The standard care
Primary Outcome Measure Information:
Title
Net change in systolic blood pressure from baseline to 3 months follow-up
Time Frame
one and three months after study
Secondary Outcome Measure Information:
Title
Net change in diastolic blood pressure
Time Frame
one and three months after study
Title
Hypertension control ratio (BP < 140/90 mmHg)
Time Frame
one and three months after study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Hou, doctor
Phone
86-13564868096
Email
Dr_houlei@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Hou
Phone
86-13564868096
Email
Dr_houlei@163.com
Facility Information:
Facility Name
Shanghai tongren hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Hou, doctor
Email
Dr_houlei@163.com
First Name & Middle Initial & Last Name & Degree
Lei Hou, doctor
Facility Name
Shanghai Tongren Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lei hou, doctor
Email
Dr_houlei@163.com
First Name & Middle Initial & Last Name & Degree
lei hou, doctor
Facility Name
Songjiang hospital, Shanghai jiaotong University, School of medicine
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Hou

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Intelligent Hypertension Intervention Study

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