TY - JOUR
T1 - Efficacy of LOw-dose DObutamine Stress-Echocardiography to predict Cardiac Resynchronization Therapy Response (LODO-CRT) multicenter prospective study-Design and rationale
AU - Muto, Carmine
AU - Gasparini, Maurizio
AU - Iacopino, Saverio
AU - Peraldo, Carlo
AU - Curnis, Antonio
AU - Sassone, Biagio
AU - Diotallevi, Paolo
AU - Davinelli, Mario
AU - Valsecchi, Sergio
AU - Tuccillo, Bernardino
PY - 2008/10
Y1 - 2008/10
N2 - Background: Although cardiac resynchronization therapy (CRT) has a well-demonstrated therapeutic effect in selected patients with advanced heart failure on optimized drug therapy, nonresponder rate remains high. The LODO-CRT is designed to improve patient selection for CRT. Design and rationale of this study are presented herein. Methods: LODO-CRT is a multicenter prospective study, started in late 2006, that enrolls patients with conventional indications for CRT (symptomatic stable New York Heart Association class III-IV on optimized drug therapy, QRS ≥120 milliseconds, left ventricular [LV] dilatation, LV ejection fraction ≤35%). This study is designed to assess the predictive value of LV contractile reserve (LVCR), determined through dobutamine stress echocardiography (defined as an LV ejection fraction increase >5 units), in predicting CRT response during follow-up. Assessment of CRT effects will follow 2 sequential phases: in phase 1, CRT response end point is defined as LV end-systolic volume reduction ≥10% at 6 months; in phase 2, both LV end-systolic volume reduction and clinical status via a clinical composite score will be evaluated at 12 months follow-up. Predictive value of LVCR will be compared to other measures, such as LV dyssynchrony measures, through adjusted multivariable analysis. For the purpose of the study, target patient number is 270 (with 95% confidence, 80% power, α ≤ .05). Enrollment should be complete by the end of 2008. Conclusions: The LODO-CRT trial is testing the hypothesis that LVCR assessment, using low-dose dobutamine stress echocardiography test, should effectively predict positive response to CRT both in terms of the reverse remodeling process as well as favorable long-term clinical outcome. Moreover, the predictive value of LVCR will be compared to that of conventional intra-LV dyssynchrony measures.
AB - Background: Although cardiac resynchronization therapy (CRT) has a well-demonstrated therapeutic effect in selected patients with advanced heart failure on optimized drug therapy, nonresponder rate remains high. The LODO-CRT is designed to improve patient selection for CRT. Design and rationale of this study are presented herein. Methods: LODO-CRT is a multicenter prospective study, started in late 2006, that enrolls patients with conventional indications for CRT (symptomatic stable New York Heart Association class III-IV on optimized drug therapy, QRS ≥120 milliseconds, left ventricular [LV] dilatation, LV ejection fraction ≤35%). This study is designed to assess the predictive value of LV contractile reserve (LVCR), determined through dobutamine stress echocardiography (defined as an LV ejection fraction increase >5 units), in predicting CRT response during follow-up. Assessment of CRT effects will follow 2 sequential phases: in phase 1, CRT response end point is defined as LV end-systolic volume reduction ≥10% at 6 months; in phase 2, both LV end-systolic volume reduction and clinical status via a clinical composite score will be evaluated at 12 months follow-up. Predictive value of LVCR will be compared to other measures, such as LV dyssynchrony measures, through adjusted multivariable analysis. For the purpose of the study, target patient number is 270 (with 95% confidence, 80% power, α ≤ .05). Enrollment should be complete by the end of 2008. Conclusions: The LODO-CRT trial is testing the hypothesis that LVCR assessment, using low-dose dobutamine stress echocardiography test, should effectively predict positive response to CRT both in terms of the reverse remodeling process as well as favorable long-term clinical outcome. Moreover, the predictive value of LVCR will be compared to that of conventional intra-LV dyssynchrony measures.
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U2 - 10.1016/j.ahj.2008.06.011
DO - 10.1016/j.ahj.2008.06.011
M3 - Article
C2 - 18926147
AN - SCOPUS:52949086756
VL - 156
SP - 656
EP - 661
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
IS - 4
ER -