Heart Failure
Conditions
Keywords
Cardiac, Resynchronization, Therapy
Brief summary
New simpler methods to optimize cardiac resynchronization therapy (CRT) are being evaluated, such as the use of the electrocardiogram. In this prospective, double-blind, study, the investigators will evaluate: Primary endpoint: To compare the clinical response to CRT in patients with the programming optimized by QRS versus the nominal suggested by the device. Secondary endpoints: 1. To compare cardiac remodeling in patients with the programming optimized by QRS versus the nominal suggested by the device. 2. To evaluate the degree of asynchrony in both groups (nominal versus optimization by QRS) with respect to the intrinsic rhythm. 3. To evaluate the echocardiographic improvement in left ventricular (LV) filling in both groups. 4. To evaluate the differences in the optimal atrioventricular (AV) delay with atrial sensing or atrial pacing. For that, 180 patients with an indication for CRT will be randomized to nominal programming of the device or optimization by the electrocardiogram for a narrower QRS. A clinical and echocardiographic evaluation will be done at baseline, 6 and 12 months.
Interventions
OTHERDevice programming: nominal
CRT device is programmed to nominal values
OTHERProgramming optimization by QRS
CRT device is programmed by QRS optimization
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
patients with standard indication of cardiac resynchronization * Ejection fraction ≤35%. * QRS duration ≥120 ms. * New York Heart Association Functional Class 2-4.. * Left ventricular diameter ≥55 mm. * Optimal medical treatment.
Exclusion criteria
* Patient refusal. * Cardiopathy with a reversible cause. * Prevision of heart transplantation. * Atrial fibrillation. * Complete AV block. * AV delay \>250 ms. * Right bundle branch block. * Severe peripheral vascular disease. * Other diseases with \< 1 year life expectancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response | 12 months | Clinical response: survival without heart transplantation or death and \>10% increased distance in the 6MWT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiographic response | 12 months | Echocardiographic response: \>15% decrease in LV end-systolic volume and survival without heart transplantation or death. |
| Pacing/sensing AV delay difference | 12 months | — |
Countries
Spain
Outcome results
None listed