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Cardiorespiratory failure is a common cause of death for patients with Duchenne muscular dystrophy (DMD). Current therapies may delay the progression of heart failure for this population. Measuring left ventricular ejection fraction (LVEF) regularly can show the rate of decline in left ventricle function for a patient.[1]

This section illustrates how the results of several systolic function tests, and accompanying data, are represented using the SDTM.

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SDTM. Basic CMR Tests - Systolic Function
SDTM. Basic CMR Tests - Systolic Function

Add text on Ejection Fraction and DMD.

The example below shows a cardiac magnetic resonance imaging procedure highlighting ejection fraction and similar cardiovascular tests. Measurements such as cardiac index and spirometry are affected by body surface area (ref: https://www.ahajournals.org/doi/10.1161/CIRCIMAGING.115.003810). It is important in the DMD population to ensure the height and weight are current for accurate data collection (especially as the participant becomes wheelchair bound). Height and weight are represented in the vital signs domain; see Section 6.3.13 of the SDTMIG v3.4 (https://www.cdisc.org/standards/foundational/sdtmig) for more information.

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For more information on the domains used in this section, see:

  • Demographics (DM) - SDTMIG v3.4, Section 5.2
  • Vital Signs (VS) - SDTMIG v3.4, Section 6.3.13
  • Cardiovascular System Findings (CV) - SDTMIG v3.4, Section 6.3.7.2
  • Laboratory Test Results (LB) - SDTMIG v3.4, Section 6.3.5.6
  • Related Records (RELREC) - SDTMIG v3.4, Section 8.2.1

The SDTMIG is available at

https://www.cdisc.org/standards/foundational/sdtmig

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SDTM. Ejection FractionSDTM. Ejection Fraction

Example

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