Non-ischemic cardiomyopathy
Conditions
Brief summary
Recurrence of left ventricular dysfunction or heart failure at 6 months (any of the following events): Decrease in LVEF >10% and LVEF <50% or; decrease in LVEF >10% and an increase in the left ventricular end-systolic volume >15% or; onset of heart failure symptoms accompanied by an elevation in NT-proBNP requiring initiation of treatment with oral, subcutaneous, or intravenous loop diuretic therapy.
Detailed description
Emergency or day care hospital visits for heart failure at 6 and 12 months, Hospital admissions for heart failure at 6 and 12 months, Ventricular arrhythmias at 6 and 12 months, Supraventricular arrhythmias at 6 and 12 months, NT-proBNP levels at 6 and 12 months, NYHA class at 6 and 12 months, Quality of life at 6 and 12 months, Recurrence of left ventricular dysfunction or heart failure (as defined for the primary endpoint) at 12 months.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence of left ventricular dysfunction or heart failure at 6 months (any of the following events): Decrease in LVEF >10% and LVEF <50% or; decrease in LVEF >10% and an increase in the left ventricular end-systolic volume >15% or; onset of heart failure symptoms accompanied by an elevation in NT-proBNP requiring initiation of treatment with oral, subcutaneous, or intravenous loop diuretic therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Emergency or day care hospital visits for heart failure at 6 and 12 months, Hospital admissions for heart failure at 6 and 12 months, Ventricular arrhythmias at 6 and 12 months, Supraventricular arrhythmias at 6 and 12 months, NT-proBNP levels at 6 and 12 months, NYHA class at 6 and 12 months, Quality of life at 6 and 12 months, Recurrence of left ventricular dysfunction or heart failure (as defined for the primary endpoint) at 12 months. | — |
Countries
Spain