| Secondary endpoints: |
---|---|
BiVp%: | |
• | BiVp% change from baseline. |
Physical competence: | |
• | 6MWT distance |
• | Peak oxygen uptake (peak VO2) in CPX |
• | NYHA functional class |
The echocardiographic assessment of the reverse remodelling: | |
• | Increase in left ventricle ejection fraction (LVEF) |
• | Decrease in left ventricle diastolic diameter and volume (LVEDD, LVEDV) |
• | Decrease in left ventricle systolic diameter and volume (LVESD, LVESV), |
• | Decrease in size of the left atrium (LA) |
• | Decrease of the severity of mitral insufficiency |
Quality of life: | |
• | Measured with the Minnesota Living with Heart Failure Questionnaire |
Clinical endpoints: | |
• | Unplanned hospitalizations due to heart failure exacerbations |
• | Death |
• | Cardiovascular death |
• | Hospitalizations due to cardiovascular causes |
• | Stroke/TIA |
• | A combined endpoint including unplanned hospitalizations due to cardiovascular causes or death |
Heart arrhythmias: | |
• | AF - using mode switch to measure time of AF with fast ventricular rate |
• | Ventricular tachycardia including torsade de pointes tachycardia and ventricular fibrillation |
In the CRT-D subgroup: | |
• | Number of adequate and inadequate shocks (separately) |
• | The prevalence of electrical storm |
Adverse events: | |
• | Pharmacotherapy related |
• | Device related |
• | Cardioversion related |
• | AVJA related |