Blood Pressure Control Target in Diabetes

  • STATUS
    Recruiting
  • End date
    Jun 24, 2024
  • participants needed
    12702
  • sponsor
    Shanghai Jiao Tong University School of Medicine
Updated on 24 January 2021
Investigator
Yu Xu, MD, PhD
Primary Contact
Ruijin hospital, Shanghai Jiaotong University School of Medicine (1.1 mi away) Contact

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.

Details
Condition Blood Pressure Control Target in Diabetes
Treatment Treatment strategy regarding different systolic BP goals
Clinical Study IdentifierNCT03808311
SponsorShanghai Jiao Tong University School of Medicine
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
-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
mmHg on 0 medication
-180 mmHg on 1 medication
-170 mmHg on up to 2 medications
-160 mmHg on up to 3 medications; or
-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
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note