NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients
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.
Timeline
- Start
- 2016-02
- Primary completion
- 2025-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bisoprolol | Other / unclassified | 10 mg | — |
| Subject | Candesartan | Unknown | 32 mg | — |
| Subject | Captopril | Small molecule | 150 mg | — |
| Subject | Carvedilol | Other / unclassified | 50 mg | — |
| Subject | Carvedilol | Other / unclassified | 100 mg | — |
| Subject | Cilazapril | Small molecule | 5 mg | — |
| Subject | Enalapril | Other / unclassified | 40 mg | — |
| Subject | Eprosartan | Small molecule | 800 mg | — |
| Subject | Fosinopril | Small molecule | 40 mg | — |
| Subject | Irbesartan | Small molecule | 300 mg | — |
| Subject | LISINOPRIL ANHYDROUS | Small molecule | 40 mg | — |
| Subject | Losartan | Other / unclassified | 150 mg | — |
| Subject | Metoprololsuccinat | Unknown | 200 mg | — |
| Subject | Nebivolol | Other / unclassified | 10 mg | — |
| Subject | Perindopril | Small molecule | 8 mg | — |
| Subject | Quinapril | Small molecule | 40 mg | — |
| Subject | Ramipril | Small molecule | 10 mg | — |
| Subject | Spirapril | Small molecule | 24 mg | — |
| Subject | Valsartan | Small molecule | 320 mg | — |
| Subject | Zofenopril | Small molecule | 60 mg | — |
| Subject | trandolapril | Small molecule | 4 mg | — |