Measuring LVEF regularly can show the rate of decline in left ventricle function for a patient with DMD. Thus Therefore, it was selected as an endpoint for this example endpoint to measure whether a course of therapy provides a slowing of may slow the progression to of heart failure for the patient. The second endpoint chosen, NT-proBNP, is a biomarker that is may be used to predict or diagnose heart failure.
This section illustrates example analysis datasets for the following endpoints:
...
The SDTM examples used as the source data are from Section 2.1, Basic Systolic Function. The readings chosen to analyze ejection fraction are the Left Ventricular Ejection Fraction, Cal, with the unit of percent. The example dataset also shows the Right Ventricular Ejection Fraction, Cal which can be used to confirm the result. The SDTM data are stored in the CV domain. The example dataset in Section 2.1 shows 2 visits for subject DMD-EF-01-101. The records for CVTESTCD = "LVEF_C" and "RVEF_C" were selected for analysis.
...