Condition: Heart Diseases · Diabetes Mellitus, Type 2 · Sponsor: Martin Huelsmann
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.
This description comes directly from the study's public registry record.
Martin Huelsmann, Doz.Dr. · +43 1 40400 · martin.huelsmann@meduniwien.ac.at
Always discuss trial participation with your own doctor first.
| Internistische Ordination | Mödling, Lower Austria, Austria | Active Not Recruiting |
| Klinischen Abteilung für Endokrinologie und Diabetologie MU Graz | Graz, Styria, Austria | Recruiting |
| Konventhospital der Barmherzigen Brüder Abteilung für Innere Medizin | Linz, Upper Austria, Austria | Recruiting |
| Krankenanstalt Rudolfstiftung, 1. Medizinische Abteilung | Vienna, Austria | Completed |
| Zentrum für Klinische Studien | Vienna, Austria | Terminated |
| Medical University of Vienna Univ.Clinic for Internal Medicine II Department of Cardiology | Vienna, Austria | Recruiting |
| Univ. Klinik für Innere Medizin III Med. Uni Wien | Vienna, Austria | Recruiting |
| Universitätsklinik für Augenheilkunde und Optometrie Medizinische Universität Wien | Vienna, Austria | Recruiting |
| Diabetes & Stoffwechselambulanz Gesundheitszentrum Wien Süd | Vienna, Austria | Recruiting |
| 3. Med. Abtlg., KH Hietzing mit Neurologischem Zentrum Rosenhügel | Vienna, Austria | Terminated |
| iMED19 | Vienna, Austria | Recruiting |
| Maastricht University Medical Center; Dep. Cardiology | Maastricht, Netherlands | Active Not Recruiting |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT02817360