Hypertension Clinical Trial
Official title:
Blood Pressure Control to Reduce Renal Risk for Type 2 Diabetes Mellitus
The BP4DM study was initiated as a prospective randomized controlled trial to investigate the renal protection effect for tight blood pressure control for Taiwanese T2DM patients without previously diagnosed CV events. We set our primary outcome for the prevention of microalbuminuria development. The secondary outcomes include mortality, annual renal function declining rate, and development of cardiovascular events. The recruitment period for the RCT trial is from 2013 Oct to 2019 Dec. In addition, we also intend to continuously follow up all our recruited hypertensive diabetes patients for at least 10 years to observe their clinical outcomes including cardiovascular, renal, retinal outcomes and mortality.
The evidence from previous literature shows importance of the blood pressure control in T2DM.
About 20% (16-29%) reduction in microalbuminuria development can be reached by continuously
lowering blood pressure level from 154/87 mmHg to 144/82 mmHg (the UKPDS), to 134.7/74.8 mmHg
(the ADVANCE study), and even to 119.3/64.4 mmHg (the ACCORD study). However, several
limitations are also inherent in the above well-known studies. First, most of the recruited
participants previous trials were Caucasians. Although 3293 Chinese patients were recruited
in the ADVANCE study, they only accounted for 29.6% of total enrollees in that trial. The
representative of Asian population is inadequate. There is also lack of domestic
evidence-based guideline designated for Taiwanese T2DM patients in optimizing their blood
pressure control. In addition, some characteristics in Asian T2DM population are different
from what have been observed in the Caucasian T2DM patients. For example, there is BMI
discrepancy between T2DM in Western and Eastern countries, more ACEi/ARB side effects (e.g.,
cough) observed in Asian population, and the possible difference in CKD/ESRD incidence in
T2DM between different ethnic groups.
Moreover, the enrollees in most well-known trials (e.g., ADVANCE and ACCORD studies) were
those who suffered from at least one cardiovascular risk factor for secondary prevention. To
our best knowledge, there is no study designed to evaluate effectiveness of blood pressure
control for T2DM patients without previous CV events. Therefore, we initiated a prospective
randomized controlled trial to investigate the renal protection effect for tight blood
pressure control for Taiwanese T2DM patients without previously diagnosed CV events. We set
our primary outcome for the prevention of microalbuminuria development to partly respond to
the urgent need for this society in solving the huge burden caused by the high incidence and
prevalence of diabetic nephropathy in Taiwan.
The study includes two parts: (1) a RCT trial, (2) an observational cohort study. The
recruitment period of this study is from 2013 Oct to 2019 Dec. The RCT trial will be ended in
2019 Dec. In addition, we also intend to continuously follow up all our recruited
hypertensive diabetes patients for at least 10 years to observe their clinical outcomes
including cardiovascular, renal, retinal outcomes and mortality (the part of the
observational cohort study).
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