Page 51 - Biomarkers for risk stratification and guidance in heart failure

Chapter 3
primary end point replaced the initial end point of reduction in number of events, as the end point of number of days alive outside the hospital included hospital admission as mortality. The primary end point was changed before any patient had been included, in the start-up phase of the study. Major secondary end points encompassed total and cardiovascular mortality, total and cardiovascular hospitalization, and the combined end points of total and cardiovascular morbidity and mortality. Furthermore, renal function, left ventricular systolic function, and age subgroups were analyzed. Additionally, analysis of the use of evidence-based HF medication was performed. Evidence-based HF medication target dose was defined as the recommended maintenance dose approved for the treatment of HF in Europe.10 Finally, it was predefined to analyze the prognostic impact of NT- proBNP levels above the individually set target level at outpatient visits.
Figure 1. Flowchart and trial outline
Overview of patients screened, reasons for exclusion, total number of patients randomized and 1 year follow-up. COPD=chronic obstructive pulmonary disease; ICD= implantable cardioverter-defibrillator; FU=follow-up; HF=heart failure; NT-proBNP=N-terminal pro–B-type natriuretic peptide; PCI=percutaneous coronary intervention; PE=pulmonary embolism.
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