Chronic Heart Failure
Conditions
Keywords
cardiac resynchronization therapy, non-responders
Brief summary
The aim of this study is to investigate the possibility of optimizing the performance of CRT-D in non-responding patients through utilization of cardiac strain speckle tracking
Detailed description
In approximately 30% of patients, cardiac resynchronization therapy (CRT) fails to lead to any improvement of the patients' status. In this study, an investigation of a possible method of optimization through speckle tracking of cardiac strains is attempted. Patients not responding to Cardiac Resynchronization Therapy-Defibrillators (CRT-D) after 3 months are randomly divided into control and intervention groups. Atrioventricular interval is adjusted so that E and A waves do not overlap and the interventricular interval subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains. The left ventricular ejection fraction (LVEF) and NYHA (New York Heart Association Classification improvement 3 months after optimization are evaluated and use of other strain combinations assessed.
Interventions
DEVICECRT-D re-programming
The previously implanted, ineffective CRT-D is reprogrammed under supervision of Trans-Thoracic Echocardiography (TTE) to: 1. adjust the atrioventricular interval so that E and A waves do not overlap 2. the interventricular interval is subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains.
DIAGNOSTIC_TESTTrans-Thoracic Echocardiography
This intervention relates to the determination of strains and atrioventricular interval and supplies data for reprogramming the ineffective CRT-D Transthoracic echocardiography performed to determine the left ventricular ejection fraction as an outcome measure is not considered intervention here (as it is also performed in the control group and that would cause an error cross-referencing.
Sponsors
University Hospital Ostrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients not responding to Cardiac Resynchronization Therapy-Defibrillators (CRT-D) after 3 months from implementation are randomly divided into control and intervention groups. Atrioventricular interval is adjusted so that E and A waves do not overlap, the interventricular interval iss subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains. The left ventricular ejection fraction (LVEF) and NYHA (New York Heart Association Classification improvement 3 months after optimization are evaluated and the use of other strain combinations assessed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with symptomatic heart failure with NYHA III/IV, pharmacological treatment options exhausted, LVEF below 30%, and QRS duration over 130ms who did not respond to the implantation of CRT-D
Exclusion criteria
* Age below 18 * response to the original CRT implantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the left ventricular ejection fraction | 6 months from CRT-D implantation, 3 months from optimization | Left ventricular ejection fraction measured by transthoracic echocardiography prior to optimizing and during a follow-up examination three month after optimizing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in NYHA Classification | 6 months from CRT-D implantation, 3 months from optimization | NYHA (New York Heart Association Classification measured using the standard NYHA range I to IV - I being the best result, IV the worst) was evaluated using a standard NYHA questionnaire before optimization and 3 months after optimization during a follow-up examination |
Countries
Czechia
Outcome results
None listed