Blood Pressure Control Target in DiabetesBPROADNCT03808311
Blood Pressure Control Target in Diabetes
A study testing Treatment strategy regarding different systolic BP goals in people with Blood Pressure Control Target in Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This is a multicenter, open-label, parallel-group, randomized controlled trial that will be conducted across mainland China. This trial will test the primary hypothesis of whether an intensive treatment strategy (a systolic blood pressure target of <120 mmHg) is more effective than a standard treatment strategy (a… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Blood Pressure Control Target in Diabetes
- What is being tested?
- Treatment strategy regarding different systolic BP goals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,821 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2019to 15 Sep 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged ≥50 years;
- Diabetes defined as:
- A self-reported previous diagnosis by health care professionals and taking anti-diabetic medications;
- Fasting plasma glucose level of ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hours;
- 2-hour plasma glucose level of ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test. The test should be performed using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water; or
- HbA1c concentration of ≥6.5% (48 mmol/mol);
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- Systolic blood pressure
- -≥140 mmHg on 0 medication;
- 130-180 mmHg on 1 medication;
- 130-170 mmHg on up to 2 medications;
- 130-160 mmHg on up to 3 medications; or
- 130-150 mmHg on up to 4 medications;
- Increased risk of cardiovascular disease (one or more of the following):
- Previous history of clinical CVD (≥ 3 months)
- Subclinical CVD within 3 years
- 2 or more CVD risk factors
- Estimated glomerular filtration rate (eGFR) 30-59 ml/min/1.73 m2
Who cannot join
- History consistent with type 1 diabetes
- Known secondary cause of hypertension
- One minute standing systolic BP <110 mmHg
- Arm circumference too large to allow accurate blood pressure measurement with available devices
- Cardiovascular event or procedure or hospitalization for unstable angina within the past 3 months
- Symptomatic heart failure within the past 6 months or left ventricular ejection fraction (by any method) <35% within the past 6 months
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- ALT or AST levels more than twice the upper limit of the normal range or active liver diseases
- Dialysis, kidney transplantation, eGFR <30 ml/min/1.73 m2, or serum creatinine >2.0 mg/dl
- Proteinuria
- Previous diagnosis of polycystic kidney disease or glomerulonephritis
- A medical condition likely to limit survival to less than 5 years
- Any factors judged by the clinic team to be likely to limit adherence to interventions
- Failure to obtain informed consent from participant
- Currently participating in another intervention study
- Currently living with another BPROAD participant
- Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Blood Pressure Control Target in Diabetes (BPROAD): a Multicenter, Open-label, Parallel-group, Randomized Controlled Trial
This is a multicenter, open-label, parallel-group, randomized controlled trial that will be conducted across mainland China. This trial will test the primary hypothesis of whether an intensive treatment strategy (a systolic blood pressure target of <120 mmHg) is more effective than a standard treatment strategy (a systolic blood pressure target of <140 mmHg) in reducing the risk of major cardiovascular disease (non-fatal stroke, non-fatal myocardial infarction, treated or hospitalized heart failure, and cardiovascular deaths) over a follow-up period of up to 5 years among patients with a history of diabetes and elevated systolic blood pressure. The secondary hypotheses are to compare the intensive blood pressure treatment strategy with the standard treatment strategy on cognitive function, individual components of the primary hypothesis, all-cause mortality, kidney outcomes, quality of life, and injurious falls, et al.
Read the detailed description
The trial will recruit 12,702 patients from approximately 150 hospitals within the China Diabetes Clinical Research Network. Eligible criteria include men and women aged ≥50 years; type 2 diabetes mellitus; elevated systolic blood pressure; and a history of clinical cardiovascular disease or increased risk for cardiovascular disease. Main exclusion criteria include known secondary cause of hypertension, symptomatic heart failure, end-stage renal disease, and other serious illness. The proposed trial has 90% statistical power to detect a 20% reduction (hazard ratio of 0.80) in major cardiovascular disease between intensive and standard treatment groups at a 2-sided significance level of 0.05.
To achieve the proposed study objectives, the following specific aims will be accomplished:
- Recruit 12,702 study participants who meet the eligibility criteria and randomly assign 6,351 to the intensive blood pressure treatment and 6,351 to the standard blood pressure treatment groups;
- Achieve and maintain two-level targets of systolic blood pressure (<120 mmHg vs. <140 mmHg) with a mean systolic blood pressure difference of ≥15 mmHg;
- Employ a study-wide strategy to encourage standard of care for all participants for the treatment of type 2 diabetes and dyslipidemia other than blood pressure;
- Obtain clinical data on study outcomes for up to 60 months of follow-up among all trial participants;
- Perform strict quality control procedures for intervention and data collection;
- Conduct data analysis according to the intention-to-treat principle; and
- Disseminate the study findings to influence clinical practice and clinical guidelines.
Findings from this trial will provide evidence as to whether intensive blood pressure management to achieve a systolic blood pressure target of <120 mmHg has additional benefits over standard management of systolic blood pressure <140 mmHg. These findings will help in the development of clinical guidelines for blood pressure management among patients with type 2 diabetes and will have important clinical impact.
- Being tested
- Treatment strategy regarding different systolic BP goals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment strategy regarding different systolic BP goalsOther
The trial will test a treatment strategy question regarding different systolic BP goals and not test specific medications. Therefore, the BP treatment protocol is flexible in terms of the choice and doses of anti-hypertensive medications as long as systolic BP levels are within targets (<120 mmHg in the intensive arm and <140 mmHg in the standard arm).
| Study group | Role | What they receive |
|---|---|---|
| Intensive BP treatment arm | Experimental | Participants in the intensive BP treatment arm will be treated to a systolic BP target of <120 mmHg. Receives: Other: Treatment strategy regarding different systolic BP goals |
| Standard BP treatment arm | Other | Participants in the standard BP treatment arm will be treated to a systolic BP target of <140 mmHg. Receives: Other: Treatment strategy regarding different systolic BP goals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiovascular events
Time to the first occurrence of any of the following: non-fatal stroke, non-fatal myocardial infarction, hospitalized or treated heart failure, or cardiovascular deaths
Measured: 5 years
Secondary outcomes (13)
A composite of the primary outcome and all-cause mortality
Time to the first occurrence of any of the following: non-fatal stroke, non-fatal MI, hospitalized or treated heart failure, or death
Measured: 5 years
Macrovascular outcome
Time to the first occurrence of any of the following: non-fatal stroke, non-fatal MI, hospitalized or treated heart failure, cardiovascular deaths, hospitalized unstable angina, or any cardiovascular revascularization procedures
Measured: 5 years
Major coronary artery diseases
Time to the first occurrence of any of the following: non-fatal MI, hospitalized unstable angina, revascularization of coronary arteries, or deaths due to coronary artery diseases
Measured: 5 years
Total MI
Fatal and non-fatal MI
Measured: 5 years
Total stroke
Fatal and non-fatal stroke
Measured: 5 years
Ischemic stroke
Fatal and non-fatal ischemic stroke
Measured: 5 years
Hemorrhagic stoke
Fatal and non-fatal hemorrhagic stoke
Measured: 5 years
Heart failure
Hospitalized or treated heart failure, or heart failure death
Measured: 5 years
Cardiovascular death
Deaths due to cardiovascular causes
Measured: 5 years
Total mortality
Deaths due to any causes
Measured: 5 years
Cognitive function
Time to the first occurrence of any of the following: all-cause dementia or mild cognitive impairment (MCI); all-cause dementia; MCI; changes in global cognitive function and in five specific cognitive domains
Measured: 5 years
Health related quality of life
Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire
Measured: 5 years
Kidney outcomes
Progression of CKD, development of CKD, and incident albuminuria
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start24 Feb 2019
- Primary completion31 May 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood Pressure Control Target in DiabetesStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12,821 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
- Investigators
- Guang Ning, MD, PhD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808311
- Sponsor's protocol ID
- Ruijin-2018-138-2
- Acronym
- BPROAD
- Status last verified
- Aug 2024
- First submitted
- 16 Dec 2018
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bi Y, Li M, Liu Y, Li T, Lu J, Duan P, Xu F, Dong Q, Wang A, Wang T, Zheng R, Chen Y, Xu M, Wang X, Zhang X, Niu Y, Kang Z, Lu C, Wang J, Qiu X, Wang A, Wu S, Niu J, Wang J, Zhao Z, Pan H, Yang X, Niu X, Pang S, Zhang X, Dai Y, Wan Q, Chen S, Zheng Q, Dai S, Deng J, Liu L, Wang G, Zhu H, Tang W, Liu H, Guo Z, Ning G, He J, Xu Y, Wang W; BPROAD Research Group. Intensive Blood-Pressure Control in Patients with Type 2 Diabetes. N Engl J Med. 2025 Mar 27;392(12):1155-1167. doi: 10.1056/NEJMoa2412006. Epub 2024 Nov 16.
PubMed 39555827Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
PubMed 36398903Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.
PubMed 32905623
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Control Target in Diabetes (BPROAD): a Multicenter, Open-label, Parallel-group, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03808311
- Acronym / sponsor ID
- BPROAD / Ruijin-2018-138-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,821 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 24 Feb 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 17 Jan 2019 (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.
This is a multicenter, open-label, parallel-group, randomized controlled trial that will be conducted across mainland China. This trial will test the primary hypothesis of whether an intensive treatment strategy (a systolic blood pressure target of <120 mmHg) is more effective than a standard treatment strategy (a systolic blood pressure target of <140 mmHg) in reducing the risk of major cardiovascular disease (non-fatal stroke, non-fatal myocardial infarction, treated or hospitalized heart failure, and cardiovascular deaths) over a follow-up period of up to 5 years among patients with a history of diabetes and elevated systolic blood pressure. The secondary hypotheses are to compare the intensive blood pressure treatment strategy with the standard treatment strategy on cognitive function, individual components of the primary hypothesis, all-cause mortality, kidney outcomes, quality of life, and injurious falls, et al.
Detailed description
The trial will recruit 12,702 patients from approximately 150 hospitals within the China Diabetes Clinical Research Network. Eligible criteria include men and women aged ≥50 years; type 2 diabetes mellitus; elevated systolic blood pressure; and a history of clinical cardiovascular disease or increased risk for cardiovascular disease. Main exclusion criteria include known secondary cause of hypertension, symptomatic heart failure, end-stage renal disease, and other serious illness. The proposed trial has 90% statistical power to detect a 20% reduction (hazard ratio of 0.80) in major cardiovascular disease between intensive and standard treatment groups at a 2-sided significance level of 0.05.
To achieve the proposed study objectives, the following specific aims will be accomplished:
- Recruit 12,702 study participants who meet the eligibility criteria and randomly assign 6,351 to the intensive blood pressure treatment and 6,351 to the standard blood pressure treatment groups;
- Achieve and maintain two-level targets of systolic blood pressure (<120 mmHg vs. <140 mmHg) with a mean systolic blood pressure difference of ≥15 mmHg;
- Employ a study-wide strategy to encourage standard of care for all participants for the treatment of type 2 diabetes and dyslipidemia other than blood pressure;
- Obtain clinical data on study outcomes for up to 60 months of follow-up among all trial participants;
- Perform strict quality control procedures for intervention and data collection;
- Conduct data analysis according to the intention-to-treat principle; and
- Disseminate the study findings to influence clinical practice and clinical guidelines.
Findings from this trial will provide evidence as to whether intensive blood pressure management to achieve a systolic blood pressure target of <120 mmHg has additional benefits over standard management of systolic blood pressure <140 mmHg. These findings will help in the development of clinical guidelines for blood pressure management among patients with type 2 diabetes and will have important clinical impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive BP treatment arm | Experimental | Other: Treatment strategy regarding different systolic BP goalsParticipants in the intensive BP treatment arm will be treated to a systolic BP target of <120 mmHg. |
| Standard BP treatment arm | Other | Other: Treatment strategy regarding different systolic BP goalsParticipants in the standard BP treatment arm will be treated to a systolic BP target of <140 mmHg. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Men and women aged ≥50 years;
- Diabetes defined as:
- Systolic blood pressure
- -≥140 mmHg on 0 medication;
- Increased risk of cardiovascular disease (one or more of the following):
Key exclusion criteria (16 listed)
- History consistent with type 1 diabetes
- Known secondary cause of hypertension
- One minute standing systolic BP <110 mmHg
- Arm circumference too large to allow accurate blood pressure measurement with available devices
- Cardiovascular event or procedure or hospitalization for unstable angina within the past 3 months
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 |
|---|---|---|
| Treatment strategy regarding different systolic BP goalsThe trial will test a treatment strategy question regarding different systolic BP goals and not test specific medications. Therefore, the BP treatment protocol is flexible in terms of the choice and doses of anti-hypertensive medications as long as systolic BP levels are within targets (<120 mmHg in the intensive arm and <140 mmHg in the standard arm). | Other | Intensive BP treatment arm, Standard BP treatment arm |
Primary outcome
Major cardiovascular events
Time frame: 5 years
Time to the first occurrence of any of the following: non-fatal stroke, non-fatal myocardial infarction, hospitalized or treated heart failure, or cardiovascular deaths
13 secondary outcomes
A composite of the primary outcome and all-cause mortality
Time frame: 5 years
Macrovascular outcome
Time frame: 5 years
Major coronary artery diseases
Time frame: 5 years
Total MI
Time frame: 5 years
Total stroke
Time frame: 5 years
Ischemic stroke
Time frame: 5 years
Hemorrhagic stoke
Time frame: 5 years
Heart failure
Time frame: 5 years
Cardiovascular death
Time frame: 5 years
Total mortality
Time frame: 5 years
Cognitive function
Time frame: 5 years
Health related quality of life
Time frame: 5 years
Kidney outcomes
Time frame: 5 years
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 23 Oct 2024.
- Derived from this study: PubMed 39555827Bi Y, Li M, Liu Y, Li T, Lu J, Duan P, Xu F, Dong Q, Wang A, Wang T, Zheng R, Chen Y, Xu M, Wang X, Zhang X, Niu Y, Kang Z, Lu C, Wang J, Qiu X, Wang A, Wu S, Niu J, Wang J, Zhao Z, Pan H, Yang X, Niu X, Pang S, Zhang X, Dai Y, Wan Q, Chen S, Zheng Q, Dai S, Deng J, Liu L, Wang G, Zhu H, Tang W, Liu H, Guo Z, Ning G, He J, Xu Y, Wang W; BPROAD Research Group. Intensive Blood-Pressure Control in Patients with Type 2 Diabetes. N Engl J Med. 2025 Mar 27;392(12):1155-1167. doi: 10.1056/NEJMoa2412006. Epub 2024 Nov 16.
- Derived from this study: PubMed 36398903Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
- Derived from this study: PubMed 32905623Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.
- Individual participant dataSharing planned: Undecided
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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.
Guang Ning, MD, PhD principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment strategy regarding different systolic BP goals in people with Blood Pressure Control Target in Diabetes, run by Shanghai Jiao Tong University School of Medicine 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 17 inclusion and 16 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 23 Oct 2024. 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?
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?
Major cardiovascular events (time frame: 5 years). 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 NCT03808311, which also lists 3 linked publications.
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 23 Oct 2024.