Trial Outcomes
death, atrial fibrillation/flutter, cardiovascular death, stroke, ventricular stroke, arrythmia, disability/incapacity, heart failure
MYOCARDIAL INFARCTION, TRANSIENT ISCHEMIC ATTACK, DEEP VEIN THROMBOSIS, STROKE, EVENT, VALVULAR HEART DISEASE, ADVERSE EVENTS, ATRIAL FIBRILLATION/FLUTTER, PULMONARY EMBOLUS, EVENTS, HEART FAILURE
The primary end point was the adjusted change in maximal LAVI measured by volumetric cardiac MRI, indexed to body surface area using the DuBois formula. Secondary outcomes were changes in NTproBNP, pulse pressure (PP), cardiac MRI measurements of structure (left ventricular end diastolic volume index, minimal LAVI, and left ventricular mass index) and function (left atrial and left ventricular stroke volume index, left atrial emptying fraction, and left ventricular ejection fraction), indirect assessment of left ventricular filling pressure using Doppler echocardiography, average ratio of early transmitral flow velocity to early diastolic mitral annular tissue velocity (E/e′), and time to first major adverse cardiovascular event over the course of the study. Major adverse cardiovascular event was defined as cardiovascular death or a serious adverse cardiovascular event due to arrythmia (including atrial fibrillation/flutter), transient ischemic attack, stroke, valvular heart disease, myocardial infarction, deep vein thrombosis or pulmonary embolus, or heart failure requiring hospital admission. Serious adverse events related to the cardiac or vascular system were defined using European Medicines Agency guidelines as events that cause death, are life threatening, require inpatient hospitalization or prolongation of existing hospitalization, or result in serious disability/incapacity.