To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive PatientsNCT05526300

Intelligent Hypertension Intervention Study

A study testing Intelligent Hypertension Management System in people with To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive Patients, run by Shanghai Tong Ren Hospital at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive Patients
What is being tested?: Intelligent Hypertension Management System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 320 participants
Where: 3 sitesChina
Study dates: 6 Sep 2022to 1 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

China3 sites

Shanghai tongren hospital
Shanghai, Shanghai Municipality, 200050
Shanghai Fifth Rehabilitation Hospital
Shanghai
Songjiang hospital, Shanghai jiaotong University, School of medicine
Shanghai

Other trials in China

About this study

Official title: 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)

Conditions: To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive Patients
Being tested: Intelligent Hypertension Management System, The standard care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intelligent Hypertension Management SystemDevice
The intelligent hypertension management system is used to remotely detect the blood pressure of hypertensive patients
The standard careOther
The standard care

Study groups in NCT05526300
Study group	Role	What they receive
The standard care group	Active comparator	Not described Receives: Other: The standard care
Intelligent intervention group	Experimental	Not described Receives: Device: Intelligent Hypertension Management System

What is being measured

The primary outcome is the main question the study is designed to answer.

Net change in systolic blood pressure from baseline to 3 months follow-up
Measured: one and three months after study

Secondary outcomes (2)

Net change in diastolic blood pressure
Measured: one and three months after study
Hypertension control ratio (BP < 140/90 mmHg)
Measured: one and three months after study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 20221 Dec 2024

First posted2 Sep 2022
Study start6 Sep 2022
Primary completion1 Dec 2024
Study completion1 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive PatientsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 320 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05526300
Sponsor's protocol ID: ShanghaiTRH-hypertension
Status last verified: Dec 2024
First submitted: 31 Aug 2022
Last updated: 21 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 38086588

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Study of Antihypertensive Intervention by Intelligent Hypertension Management System
ClinicalTrials.gov ID: NCT05526300
Acronym / sponsor ID: ShanghaiTRH-hypertension
Conditions: To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive Patients
Study type: Interventional
Recruitment status: Completed
Enrolment: 320 participants (actual)
Lead sponsor: Shanghai Tong Ren HospitalUniversity, hospital or other
Study start: 6 Sep 2022 (actual)
Primary completion: 1 Dec 2024 (actual)
Study completion: 1 Dec 2024 (actual)
First posted: 2 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
The standard care group	Active comparator	Other: The standard care
Intelligent intervention group	Experimental	Device: Intelligent Hypertension Management System

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intelligent Hypertension Management SystemThe intelligent hypertension management system is used to remotely detect the blood pressure of hypertensive patients	Device	Intelligent intervention group
The standard careThe standard care	Other	The standard care group

Primary outcome

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

2 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
Derived from this study: PubMed 38086588Yu 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.
Individual participant dataSharing planned: Yes. 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Net change in systolic blood pressure from baseline to 3 months follow-up (time frame: one and three months after study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05526300, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.