Dobutamine Stress Echocardiography in Cardiac Resynchronization Therapy (CRT) Patients Selection (LODO-CRT)
Recruitment status was Active, not recruiting
While cardiac resynchronization therapy (CRT) has a well demonstrated therapeutic effect in selected patients with advanced heart failure (HF) on optimized drug therapy, non-responder rate remains high. The low-dose dobutamine stress-echo (DSE) test to predict positive response to CRT (LODO-CRT) trial is designed to improve patient selection for CRT.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Efficacy Of Low-Dose Dobutamine Stress-Echocardiography To Predict Cardiac Resynchronization Therapy Response|
- Number of patients showing left ventricular reverse remodelling. In particular, a 10% or greater reduction of the left ventricular end-systolic volume (LVESV) is the primary endpoint of the LODO-CRT study. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Clinical composite score, which combines changes in the NYHA class and global assessment with the information provided from the occurrence of major clinical events. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Estimated Study Completion Date:||September 2009|
|Estimated Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
LODO-CRT is a multicenter prospective study enrolling HF patients with conventional indication to CRT (symptomatic stable NYHA class III-IV on optimized drug therapy, QRS≥120 msec, left ventricular (LV) dilatation, LVEF≤35%) is designed to assess the predictive value of LV contractile reserve (LVCR), determined through DSE, in predicting CRT response during follow-up. Assessment of CRT effects will follow two sequential phases: in phase 1 CRT response end-point is defined as left ventricular end-systolic volume (LVESV) reduction ≥ 10% at 6 months; in phase 2, both LVESV 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 patients (with 95% confidence, 80% power, α≤0.05).
LVCR assessment, using low-dose DES 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828360
|Istituto Clinico Humanitas|
|Milan, Italy, 20100|
|Ospedale Santa Maria di Loreto Mare|
|Naples, Italy, 80142|
|Santa Maria della Misericordia|
|Principal Investigator:||Carmine Muto, MD||Ospedale Santa Maria di Loreto Mare Naples|