Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Cardiovascular mortality (composite) |
Rates of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 2,3,4,5,6) |
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU) |
|
Primary |
Hospitalisation for cardiovascular event (composite) |
Rates of cardiovascular mortality, hospitalization for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,3,4,5,6) |
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU) |
|
Primary |
Worsening of NYHA stage (composite) |
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,2,4,5,6) |
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU) |
|
Primary |
Onset of ventricular arrhythmia (composite) |
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1, 2,3, 5,6) |
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU) |
|
Primary |
Onset of supra ventricular arrhythmia (composite) |
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1, 2,3,4,6) |
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU) |
|
Primary |
Onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (composite) |
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,2,3,4,5) |
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU) |
|
Secondary |
Onset of tachycardia and or atrial fibrillation |
Tachycardia and/or ventricular fibrillation during follow-up as well as sudden death, recovered or not recovered. (With outcome 8) |
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU) |
|
Secondary |
Sudden death, recovered or not recovered |
Tachycardia and/or ventricular fibrillation during follow-up as well as sudden death, recovered or not recovered. (With outcome 7) |
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU) |
|
Secondary |
Cardiac decompensation requiring IV diuretics intake |
Composite endpoint: cardiac decompensation requiring IV diuretics intake (managed in conventional hospitalization, day hospitalization or in-home) and the occurrence of atrial fibrillation, atrial tachycardia or atrial flutter. (With outcome 10) |
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU) |
|
Secondary |
Occurrence of atrial fibrillation, atrial tachycardia or atrial flutter |
Composite endpoint: cardiac decompensation requiring IV diuretics intake (managed in conventional hospitalization, day hospitalization or in-home) and the occurrence of atrial fibrillation, atrial tachycardia or atrial flutter. (With outcome 9) |
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU) |
|
Secondary |
Cardiac remodelling |
Evaluated by measurement of left ventricular mass as well as the appearance of late enhancement on MRI. |
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU) |
|
Secondary |
Cardiac remodelling |
Evaluated by measurement of volume as well as the appearance of late enhancement on MRI. |
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU) |
|
Secondary |
Cardiac remodelling |
Evaluated by measurement of function as well as the appearance of late enhancement on MRI. |
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU) |
|