NCT02817360 NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients
| NCT ID | NCT02817360 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Martin Huelsmann |
| Condition | Heart Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2016-02 |
| Primary Completion | 2025-12 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Type-2 diabetes for at least six months, 2. ≥ 18 years of age, men or female, 3. Written informed consent to participate in the study and ability to comply with all requirements. Exclusion Criteria: 1. History of hypersensitivity to any of the investigated drugs as well as known or suspected contraindications to the study drugs or previous history of intolerance to high dose of RAS-Antagonist or Beta-blocker in the absence of any other blood pressure lowering drugs. 2. Patients already on maximum dose of RAS-antagonist or beta-blocker. 3. Creatinine \> 2.5mg/dl. 4. Symptomatic hypotension and/or systolic blood pressure (SBP) \< 100 mmHg at Visit 1. 5. Symptomatic bradycardia and/or heart rate (HR) \< 60 bpm at Visit 1 6. Signs of cardiac disease in the ECG such as atrial fibrillation; ST-T abnormalities or any bundle branch block / higher degree atrioventricular (AV) block. 7. Abnormal echocardiography, defined as low ejection fraction \< 50%; wall motion abnorma