Yes! Outpatient encounters includes emergency room or infusion clinic visits for IV diuretic qualifies as a recent primary diagnosis of heart failure encounter.
No, biobank/future use samples are not currently planned in any country.
The broad term of “event” includes both safety and efficacy, but those terms differentiate AEs and potential endpoint events. There should not be duplicate reporting.
In the usual care arm, the principal investigator (PI) may prescribe any medications deemed necessary based on standard clinical management and current guideline recommendations. Participation in the study should not influence the management of subjects in the usual care arm. The objective is to compare the rapid initiation of combination therapy in the intervention arm to usual care, which often involves delays in the initiation of guideline-directed medical therapy (GDMT). Therefore, selecting the appropriate patient population is critical to the success of the CONFIRMATION-HF study.
The exclusion for 30 days after acute myocardial infraction refers specifically to type 1 myocardial infarction. Type 1 myocardial infarction (MI) is defined as an MI caused by atherothrombotic coronary artery disease, usually precipitated by atherosclerotic plaque disruption (rupture or erosion) with partial or complete vessel thrombosis. Troponin elevation due to heart failure or other stress related blood stream troponin elevation are not exclusionary.