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Blood Pressure Control Target in Diabetes

NCT03808311 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12821

Last updated 2024-10-23

No results posted yet for this study

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 cognitive function, individual components of the primary hypothesis, all-cause mortality, kidney outcomes, quality of life, and injurious falls, et al.

Conditions

  • Blood Pressure Control Target in Diabetes

Interventions

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).

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Guang Ning, MD, PhD · Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-24
Primary Completion
2024-05-31
Completion
2024-09-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03808311 on ClinicalTrials.gov