Blood Pressure Control Target in Diabetes

Blood Pressure Control Target in Diabetes Clinical Trial

— BPROAD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03808311
• Other study ID #: Ruijin-2018-138-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 24, 2019
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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:

1. 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;

2. 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;

3. 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;

4. Obtain clinical data on study outcomes for up to 60 months of follow-up among all trial participants;

5. Perform strict quality control procedures for intervention and data collection;

6. Conduct data analysis according to the intention-to-treat principle; and

7. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12821
• Est. completion date: June 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Men and women aged =50 years;

2. 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);

3. 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;

4. 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:

1. History consistent with type 1 diabetes

2. Known secondary cause of hypertension

3. One minute standing systolic BP <110 mmHg

4. Arm circumference too large to allow accurate blood pressure measurement with available devices

5. Cardiovascular event or procedure or hospitalization for unstable angina within the past 3 months

6. Symptomatic heart failure within the past 6 months or left ventricular ejection fraction (by any method) <35% within the past 6 months

7. ALT or AST levels more than twice the upper limit of the normal range or active liver diseases

8. Dialysis, kidney transplantation, eGFR <30 ml/min/1.73 m2, or serum creatinine >2.0 mg/dl

9. Proteinuria

10. Previous diagnosis of polycystic kidney disease or glomerulonephritis

11. A medical condition likely to limit survival to less than 5 years

12. Any factors judged by the clinic team to be likely to limit adherence to interventions

13. Failure to obtain informed consent from participant

14. Currently participating in another intervention study

15. Currently living with another BPROAD participant

16. Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control

Related Conditions & MeSH terms

• Blood Pressure Control Target in Diabetes
• Diabetes Mellitus

Intervention

Other:
• Treatment strategy regarding different systolic BP goals
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).

Locations

Country	Name	City	State
China	Ruijin hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All cardiovascular revascularization procedures		5 years
Other	Treated or hospitalized unstable angina		5 years
Other	Retinopathy		5 years
Other	Transient ischemic attack (TIA)		5 years
Other	Left ventricular hypertrophy (LVH)		5 years
Other	Atrial fibrillation or flutter		5 years
Other	All cancers	Time to the first occurrence of any types of cancer	5 years
Other	Cost-effectiveness	The incremental cost per quality adjusted life year (QALY) gained. QALYs will be measured by the EuroQol-5 Dimensions (EQ-5D) questionnaire.	5 years
Primary	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	5 years
Secondary	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	5 years
Secondary	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	5 years
Secondary	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	5 years
Secondary	Total stroke	Fatal and non-fatal stroke	5 years
Secondary	Heart failure	Hospitalized or treated heart failure, or heart failure death	5 years
Secondary	Cardiovascular death	Deaths due to cardiovascular causes	5 years
Secondary	Total mortality	Deaths due to any causes	5 years
Secondary	Cognitive function	Incidence of all-cause dementia	5 years
Secondary	Health related quality of life	Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire	5 years
Secondary	Kidney outcomes	Progression of CKD, development of CKD, and incident albuminuria	5 years