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Blood Pressure Control Target in Diabetes (BPROAD)

Primary Purpose

Blood Pressure Control Target in Diabetes

Status

Active

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Treatment strategy regarding different systolic BP goals

About this trial

This is an interventional treatment trial for Blood Pressure Control Target in Diabetes

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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);
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

Exclusion Criteria:

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
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

Sites / Locations

Ruijin hospital, Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intensive BP treatment arm

Standard BP treatment arm

Arm Description

Participants in the intensive BP treatment arm will be treated to a systolic BP target of <120 mmHg.

Participants in the standard BP treatment arm will be treated to a systolic BP target of <140 mmHg.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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, treated or hospitalized unstable angina, or any cardiovascular revascularization procedures

Major coronary artery diseases

Time to the first occurrence of any of the following: non-fatal MI, treated or hospitalized unstable angina, revascularization of coronary arteries, or deaths due to coronary artery diseases

Total stroke

Fatal and non-fatal stroke

Heart failure

Hospitalized or treated heart failure, or heart failure death

Cardiovascular death

Deaths due to cardiovascular causes

Total mortality

Deaths due to any causes

Cognitive function

Incidence of all-cause dementia

Health related quality of life

Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire

Kidney outcomes

Progression of CKD, development of CKD, and incident albuminuria

Full Information

NCT ID

NCT03808311

First Posted

December 16, 2018

Last Updated

May 21, 2023

Sponsor

Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03808311

Brief Title

Blood Pressure Control Target in Diabetes

Acronym

BPROAD

Official Title

Blood Pressure Control Target in Diabetes (BPROAD): A Multicenter, Open-label, Parallel-group, Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 24, 2019 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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 dementia and 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 200 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blood Pressure Control Target in Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

12821 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intensive BP treatment arm

Arm Type

Experimental

Arm Description

Participants in the intensive BP treatment arm will be treated to a systolic BP target of <120 mmHg.

Arm Title

Standard BP treatment arm

Arm Type

Other

Arm Description

Participants in the standard BP treatment arm will be treated to a systolic BP target of <140 mmHg.

Intervention Type

Other

Intervention Name(s)

Treatment strategy regarding different systolic BP goals

Intervention Description

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).

Primary Outcome Measure Information:

Title

Major cardiovascular events

Description

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

A composite of the primary outcome and all-cause mortality

Description

Time to the first occurrence of any of the following: non-fatal stroke, non-fatal MI, hospitalized or treated heart failure, or death

Time Frame

5 years

Title

Macrovascular outcome

Description

Time Frame

5 years

Title

Major coronary artery diseases

Description

Time to the first occurrence of any of the following: non-fatal MI, treated or hospitalized unstable angina, revascularization of coronary arteries, or deaths due to coronary artery diseases

Time Frame

5 years

Title

Total stroke

Description

Fatal and non-fatal stroke

Time Frame

5 years

Title

Heart failure

Description

Hospitalized or treated heart failure, or heart failure death

Time Frame

5 years

Title

Cardiovascular death

Description

Deaths due to cardiovascular causes

Time Frame

5 years

Title

Total mortality

Description

Deaths due to any causes

Time Frame

5 years

Title

Cognitive function

Description

Incidence of all-cause dementia

Time Frame

5 years

Title

Health related quality of life

Description

Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire

Time Frame

5 years

Title

Kidney outcomes

Description

Progression of CKD, development of CKD, and incident albuminuria

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

All cardiovascular revascularization procedures

Time Frame

5 years

Title

Treated or hospitalized unstable angina

Time Frame

5 years

Title

Retinopathy

Time Frame

5 years

Title

Transient ischemic attack (TIA)

Time Frame

5 years

Title

Left ventricular hypertrophy (LVH)

Time Frame

5 years

Title

Atrial fibrillation or flutter

Time Frame

5 years

Title

All cancers

Description

Time to the first occurrence of any types of cancer

Time Frame

5 years

Title

Cost-effectiveness

Description

The incremental cost per quality adjusted life year (QALY) gained. QALYs will be measured by the EuroQol-5 Dimensions (EQ-5D) questionnaire.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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); 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guang Ning, MD, PhD

Organizational Affiliation

Shanghai Jiao Tong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ruijin hospital, Shanghai Jiaotong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

36398903

Citation

Saiz 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.

Results Reference

derived

PubMed Identifier

32905623

Citation

Saiz 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.

Results Reference

derived

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Blood Pressure Control Target in Diabetes

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