Outcomes: Primary and Secondary End Points
interstitial cardiac fibrosis, LV stroke
ADVERSE EVENTS, SECONDARY, INSULIN SENSITIVITY
To assess both structural and functional aspects of LV remodeling, 2 equally ranked primary end points were chosen: (1) a change in LVMI (in grams per meters squared) measured with cardiac MRI at baseline, 6 months, and 12 months after randomization; and (2) a change in diastolic function, assessed as the ratio of peak early transmitral ventricular filling velocity to early diastolic tissue Doppler velocity (E/e′) measured with echocardiography at baseline, 6 months, and 12 months after randomization.The following key secondary end points were evaluated: interstitial cardiac fibrosis (extracellular volume fraction), LA volume index, LV stroke volume index, right ventricular (RV) EF (all by cardiac MRI), maximal exercise capacity (peak oxygen consumption), insulin sensitivity (HOMA), and NT-proBNP at 12 months. Additional secondary end points are listed in the eMethods in Investigators duly documented and reported all adverse events (AEs), including serious AEs, to the Universität Leipzig Clinical Trial Centre, which passed them immediately to the trial coordinator for medical assessment and a second opinion with respect to the causal relationship with the trial medication. All study procedures followed good clinical practice rules.