Echocardiography Guided Optimisation of Cardiac Resynchronization Therapy Late after Implantation

Category Primary study
Registry of TrialsANZCTR
Year 2012
INTERVENTION: Heart failure patients with cardiac resynchronization therapy (CRT) devices will be investigated in a 2 stage trial investigating whether no optimization or echocardiographic CRT optimization, either at rest or on exercise, is advantageous. Optimization will occur by adjusting both the atrioventricular (AV) and ventriculo‐ventricular (VV) delay of the CRT device. Stage 1 ‐ individuals will either be randomized to no optimization or resting optimization. For this we will use the iterative method for the AV delay and the Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI) method for the VV delay. Stage 2 ‐ individuals will either be randomized to resting optimization (as in stage 1) or optimization just on completion of a 6 minute walk test (exercise optimization). Resting optimization will be as in stage 1. On exercise (6 minute walk) we will only adjust the VV delay using the difference in time to systolic peak contraction between opposing LV segments at rest and then on exercise. Individuals will thus be optimized twice in total. At each visit they will undergo a resting echocardiogram, blood testing and measures of functional capacity such as treadmill walking and 6 minute walk test distance. Once at the start of stage 1 (month 1) and then at the start of stage 2 (month 7). Each optimization takes roughly 90 mins once per 6 months. CONDITION: Heart Failure PRIMARY OUTCOME: Functional improvement assessed using standard heart failure mechanisms ‐ 6 minute walk distance, treadmill time, peak oxygen consumption on exercise (VO2 max), brain natriuretic peptide (BNP). SECONDARY OUTCOME: Echocardiographic improvement in terms of ventricular function and ventricular synchrony. We will measure Simpsons biplane ejection fraction as a measure of left ventricular function and compare change from the start of each stage to the end. we will use the standard deviation fo the time to peak systolic contraction as a measure of left ventricular dyssychrony. Again we will compare change from the start of each stage to the end. INCLUSION CRITERIA: We studied individuals who had undergone CRT implantation and were able to perform moderate exercise to level of completion of 6 minute walk test.
Epistemonikos ID: 485bc308db330e4ccea1d98a87b1559dd8e8d53c
First added on: Aug 25, 2024