Home Blood PressureNCT05858944
Home Blood Pressure Intervention in the Community Trial
A study of Home Blood Pressure, run by Shanghai Institute of Hypertension at 1 site in China.
Trial summary
The primary purpose of the study is to explore whether a lower home blood pressure target (125/75 v.s. 135/85 mmHg) would be beneficial to elderly treated hypertensive patients in terms of reduced incidence of cardiovascular events. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Home Blood Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2023to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60-80 years old
- Have been taking antihypertensive drugs for more than 2 weeks
- The average SBP and/or DBP of 7-day home blood pressure monitoring ≥135/85 mmHg
- Willing to participate, adhere to follow-up, and sign the written informed consent form
Who cannot join
- Arm circumference too large or too small (less than 18 cm or greater than 42 cm) to fit the cuff in case of inaccurate measurement
- Invalid home blood pressure monitoring. The valid home blood pressure monitoring requires consecutive measurements for at least 3 days, with not less than 1 measurement in the morning and evening, respectively.
- Office blood pressure indicates stage 3 clinic hypertension (≥180/110 mmHg) during the screening period
- Suspected or known secondary hypertension
- Orthostatic hypotension, defined as a decrease in systolic blood pressure greater than 20 mmHg or diastolic blood pressure greater than 10 mmHg within 3 minutes when position is changed from sitting to standing
- eGFR<30 ml/min/1.73m2 or end-stage renal disease
Show all 10Show fewer
- Cardiovascular events occured within the past 3 months, such as myocardial infarction, stroke, acute heart failure, hospitalization for unstable angina, undergoing coronary artery revascularization or bypass grafting
- Abnormal liver function (ALT/AST/total bilirubin more than 2 times the upper limit of normal value)
- Severe somatic disease with a life expectancy of less than 3 years, or diagnosed with cancer within the past 2 years requiring treatment
- Doctors deem that the participation would do harm to the patients or the patients would have poor compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Community hospitals
Shanghai, Shanghai Municipality, 200025
Yan Li, Professor, +8613482234463, liyanshcn@163.com
Yan Li, Professor
About this study
The primary purpose of the study is to explore whether a lower home blood pressure target (125/75 v.s. 135/85 mmHg) would be beneficial to elderly treated hypertensive patients in terms of reduced incidence of cardiovascular events. The study also aims to promote the application of standardised and information-based home blood pressure monitoring in community hypertension management.
- Conditions
- Home Blood Pressure
- Being tested
- Intensive Home BP control, Standard Home BP control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Home BP controlDrug
Also called Home BP<125/75 mmHg
If the target home BP level is not achieved during the follow-up periods, type and dosage of antihypertensive drugs will be adjusted according to current guidelines and physician's clinical experience.
Standard Home BP controlDrug
Also called Home BP<135/85 mmHg
If the target home BP level is not achieved during the follow-up periods, type and dosage of antihypertensive drugs will be adjusted according to current guidelines and physician's clinical experience.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Home BP Control | Experimental | Participants randomized into the intensive treatment arm will have a goal of home BP<125/75 mmHg. Receives: Drug: Intensive Home BP control |
| Standard Home BP Control | Active comparator | Participants randomized into the standard treatment arm will have a goal of home BP within 125-134/75-84 mmHg. Receives: Drug: Standard Home BP control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of adverse cardiovascular events
Composite of major adverse cardiovascular events consisting of death from cardiovascular diseases, non-fatal stroke, myocardial infarction, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), hospitalization for heart failure or unstable agina.
Measured: 48 months
Secondary outcomes (3)
Components of the primary outcome
Occurrence of any components of the primary outcome (death from cardiovascular diseases, non-fatal stroke, myocardial infarction, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), hospitalization for heart failure or unstable agina).
Measured: 48 months
Renal outcome
Including end stage renal disease (ESRD) and a decrease in the eGFR of 30% or more
Measured: 48 months
Adverse or severe adverse events
Especially dizziness and falls caused by hypotension, and orthostatic hypotension
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start6 May 2023
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
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 Home Blood PressureStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Hypertension
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Li, Shanghai Institute of Hypertension
- Investigators
- Yan Li, Professor, Principal investigator, Shanghai Institute of HypertensionJiguang Wang, Professor, Principal investigator, Shanghai Institute of Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858944
- Sponsor's protocol ID
- 1.1
- Status last verified
- Jan 2025
- First submitted
- 5 May 2023
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang DY, Zhang YQ, An DW, Cheng YB, Tang ST, Liu M, Li J, Staessen JA, Wang JG, Li Y; HomeBP Trial Investigators. A randomised trial comparing usual versus strict home blood pressure control in elderly patients with hypertension: protocol and initial progress. Blood Press. 2025 Dec;34(1):2472192. doi: 10.1080/08037051.2025.2472192. Epub 2025 Mar 2.
PubMed 39993302
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Blood Pressure Intervention in the Community Trial
- ClinicalTrials.gov ID
- NCT05858944
- Acronym / sponsor ID
- 1.1
- Conditions
- Home Blood Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Shanghai Institute of HypertensionUniversity, hospital or other
- Study start
- 6 May 2023 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 15 May 2023 (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.
The primary purpose of the study is to explore whether a lower home blood pressure target (125/75 v.s. 135/85 mmHg) would be beneficial to elderly treated hypertensive patients in terms of reduced incidence of cardiovascular events. The study also aims to promote the application of standardised and information-based home blood pressure monitoring in community hypertension management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Home BP Control | Experimental | Drug: Intensive Home BP controlParticipants randomized into the intensive treatment arm will have a goal of home BP<125/75 mmHg. |
| Standard Home BP Control | Active comparator | Drug: Standard Home BP controlParticipants randomized into the standard treatment arm will have a goal of home BP within 125-134/75-84 mmHg. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 60-80 years old
- Have been taking antihypertensive drugs for more than 2 weeks
- The average SBP and/or DBP of 7-day home blood pressure monitoring ≥135/85 mmHg
- Willing to participate, adhere to follow-up, and sign the written informed consent form
Key exclusion criteria (10 listed)
- Arm circumference too large or too small (less than 18 cm or greater than 42 cm) to fit the cuff in case of inaccurate measurement
- Invalid home blood pressure monitoring. The valid home blood pressure monitoring requires consecutive measurements for at least 3 days, with not less than 1 measurement in the morning and evening, respectively.
- Office blood pressure indicates stage 3 clinic hypertension (≥180/110 mmHg) during the screening period
- Suspected or known secondary hypertension
- Orthostatic hypotension, defined as a decrease in systolic blood pressure greater than 20 mmHg or diastolic blood pressure greater than 10 mmHg within 3 minutes when position is changed from sitting to standing
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 |
|---|---|---|
| Intensive Home BP controlAlso: Home BP<125/75 mmHgIf the target home BP level is not achieved during the follow-up periods, type and dosage of antihypertensive drugs will be adjusted according to current guidelines and physician's clinical experience. | Drug | Intensive Home BP Control |
| Standard Home BP controlAlso: Home BP<135/85 mmHgIf the target home BP level is not achieved during the follow-up periods, type and dosage of antihypertensive drugs will be adjusted according to current guidelines and physician's clinical experience. | Drug | Standard Home BP Control |
Primary outcome
Composite of adverse cardiovascular events
Time frame: 48 months
Composite of major adverse cardiovascular events consisting of death from cardiovascular diseases, non-fatal stroke, myocardial infarction, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), hospitalization for heart failure or unstable agina.
3 secondary outcomes
Components of the primary outcome
Time frame: 48 months
Renal outcome
Time frame: 48 months
Adverse or severe adverse events
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Derived from this study: PubMed 39993302Zhang DY, Zhang YQ, An DW, Cheng YB, Tang ST, Liu M, Li J, Staessen JA, Wang JG, Li Y; HomeBP Trial Investigators. A randomised trial comparing usual versus strict home blood pressure control in elderly patients with hypertension: protocol and initial progress. Blood Press. 2025 Dec;34(1):2472192. doi: 10.1080/08037051.2025.2472192. Epub 2025 Mar 2.
Related trials for Home Blood Pressure
Active, not recruiting
Implementing a Home Blood Pressure Monitoring Program in Primary Care
Hypertension
Active, not recruiting
Patient-driven Management of BP in CKD
Chronic Kidney Disease
Active, not recruiting
Conquering Hypertension in Urban Vietnam
Hypertension
Not yet recruiting
Monitoring Blood Pressure at Home and Pharmacy Telehealth Among People Living With HIV
Hypertension, Blood Pressure Monitoring
Recruiting
Evaluation of a Health System Integrated Model for Postpartum Education and Support in Rural Populations
Health Care Utilization
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.
Yan Li, Professor principal investigator
Shanghai Institute of Hypertension
Jiguang Wang, Professor principal investigator
Shanghai Institute of Hypertension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Home Blood Pressure, run by Shanghai Institute of Hypertension at 1 site in China.
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 10 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: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Li, Professor (+8613482234463, liyanshcn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of adverse cardiovascular events (time frame: 48 months). 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 NCT05858944, 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 6 Jan 2025.