NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients
Status:
Unknown status
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
Summary
Purpose and rationale The purpose of this study is to evaluate the effect of high dose
Renin-Angiotensin System (RAS)-antagonists and beta-blocker treatment for the primary
prevention of cardiac events in a population of patients with Type 2 diabetes mellitus (T2DM)
with no evidence of a preexisting cardiac disease. An additional aim is to demonstrate an
interaction between concentrations of amino-terminal pro-B type natriuretic peptide
(NT-proBNP as a surrogate of imminent cardiac risk) and treatment effects and the economic
impact of the intervention overall and in the biomarker stratified subgroups.
Primary objective Superiority of high dose treatment with RAS-antagonists and beta-blockers
compared to conventional therapy regarding the reduction of unplanned hospitalization or
death due to a cardiac event in T2DM patients with a NT-proBNP > 125pg/ml.
There is an additional eye-substudy for Viennese sites only. The purpose of this sub-study is
to evaluate the effect of high dose RAS-antagonists and beta blocker treatment on early
subclinical signs of diabetic micro-angiopathy and neuropathy. An additional aim will be the
evaluation of the possible impact of the cardiovascular risk factor NT-proBNP on the onset
and progression of diabetic retinopathy.