Efficacy outcomes | Definitions |
---|---|
6-min walk test | Treadmill walking test to test exercise capacity in patients with chronic heart failure [60]. |
NYHA class reduction | Estimation of NYHA functional class [61] within 6 months after randomization [62] |
LVEF improvement | Measured using 2-dimenionsonal Doppler-flow echocardiography [63] or used LV volume reduction |
Peak oxygen consumption (pVO2) | Measurement of peak oxygen consumption per unit time at anaerobic threshold. The improvement will be assessed from baseline to 6 months [64] |
Hospitalization | NA |
All-cause mortality | NA |
Quality of life | Questionnaire developed to assess patients perception on the impact of heart failure on their daily lifestyle [65] |
Heart failure hospitalization | Includes patients that were admitted to any health facility for the treatment of heart failure symptoms for more than 24 h [66] |
Composite response endpoint | Worsened: Patient death, worsening of heart failure resulting in hospitalization, therapeutic response is considered insufficient, worsening in NYHA class relative to previous observation or moderate-marked worsening of patient global assessment score at LOCF (last observation carried forward). Improved: Patient has not worsened (as previously described) and shows improvement in NYHA class at LOCF and/or moderate-marked improvement in patient global assessment score at LOCF. Unchanged: No indications of worsened nor improved health of patients [62]. |
All-cause mortality composite outcomes | All-cause mortality in combination with any other outcomes |