Abstract
Background Right ventricular (RV) failure is a major complication of pulmonary arterial hypertension (PAH). Cardiovascular magnetic resonance (CMR) can accurately quantify RV volume and function. Short-term changes in CMR measurements of RV size and function in PAH patients on individualized therapy have not been extensively studied; therefore, the required sample size for detecting a certain change in RV size and function in response to therapy is unknown. This study was designed to (1) assess changes in RV size and function in patients on individualized PAH treatment, and (2) to estimate sample sizes needed to detect a change in RV function in future PAH drug trials without discontinuing standard therapy.
Highlights
Right ventricular (RV) failure is a major complication of pulmonary arterial hypertension (PAH)
Treatment, and (2) to estimate sample sizes needed to detect a change in RV function in future PAH drug trials without discontinuing standard therapy
After 6 months, 53% had an increase in ejection fraction (EF)≥3% and 26% an increase in EF≥5%, in the overall cohort, there was no significant difference over time in either mean RV end-diastolic volume index (RVEDVI) (ΔEDVI 3±17ml/m2, NS) or mean RVEF (ΔEF 1±4%, NS) (Figure)
Summary
Designing pulmonary arterial hypertension trials for detecting change in right ventricular function using cardiovascular magnetic resonance: what is the appropriate sample size?. Karima Addetia*, Nicole M Bhave, Benjamin H Freed, Mardi Gomberg-Maitland, Wendy Tsang, Victor Mor-Avi, Lira Palen, Kirk Spencer, Karin Dill, Roberto Lang, Amit R Patel. From 16th Annual SCMR Scientific Sessions San Francisco, CA, USA. From 16th Annual SCMR Scientific Sessions San Francisco, CA, USA. 31 January - 3 February 2013
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