Heart Failure
Conditions
Brief summary
The purpose of this study is to determine the role of ivabradine in cardiac resynchronization recipients with an unsatisfactory percentage biventricular pacing. The study protocol 60 patients with heart failure NYHA (New York Heart Association) II-IV treated with optimal medical therapy as clinically indicated who received CRT-D device more than 3 months ago. Patients with biventricular pacing \<95% will and heart rate \<70 at rest and \>50% of heart rate in device memory \>70 will receive ivabradine. The minimal follow-up of patients in the study will be at least six months.
Detailed description
Approximately 30% of CRT recipients do not respond to therapy. One of the causes ot that is unsatisfactory percentage of biventricular pacing. Patients may loose biventricular pacing because of inadequate sinus tachycardia. Ivabradine may prevent inadequate sinus tachycardia and improve quality of live of CRT recipients. According to current guidelines ivabradine is recommended in patients with symptomatic heart failure with heart rate at rest \>70. The hypothesis of this study is that ivabradine may increase percentage of biventricular pacing in CRT recipients who have unsatisfactory percentage of biventricular pacing and \>50% of heart rate in device memory \>70.
Interventions
DRUGIvabradine
Ivabradine 5 mg twice a day or 7,5 mg twice a day
Sponsors
Medical University of Warsaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* heart failure NYHA II-IV * left ventricular ejection fraction =\<35% * CRT-D implanted over 3 months ago * optimal CRT-D parameters * biventricular pacing \<95% despite the optimal parameters of the device * optimal pharmacotherapy with the highest well-tolerated beta-adrenolytic dosage * heart rate at rest below 70 bpm * over 50% of heart rhythm over 70 bpm at interrogation with the device
Exclusion criteria
* persistent atrial fibrillation/flutter * device associated ineffective resynchronization * contraindications to ivabradine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of biventricular pacing >95% | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of biventricular pacing >98% | 6 months |
| Time to first inappropriate shock | 6 months |
| change of mean heart rate compared with baseline | 6 months |
| The change between baseline and final echocardiographic parameters | 6 months |
| The assessment of quality of life (SF36) | 6 months |
| The change between baseline and final NYHA class | 6 months |
| Cardiovascular hospitalization | 6 months |
Other
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | 6 months |
Countries
Poland
Contacts
Primary ContactMarcin Grabowski, PhD
Backup ContactLukasz Januszkiewicz, MD
Outcome results
None listed