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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivabradine | Experimental | Ivabradine 5 mg twice a day or 7,5 mg twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivabradine | Drug | Ivabradine 5 mg twice a day or 7,5 mg twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of biventricular pacing >95% | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of biventricular pacing >98% | 6 months | |
| Time to first inappropriate shock | 6 months | |
| change of mean heart rate compared with baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcin Grabowski, PhD | Contact | +48 660 751 816 | marcin.grabowski@wum.edu.pl | |
| Lukasz Januszkiewicz, MD | Contact | +48 694 333 056 | lukasz.jan.januszkiewicz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcin Grabowski, MD | Medical University of Warsaw | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Department of Cariology of Medcial University of Warsaw | Warsaw | Masovian Voivodeship | 02-097 | Poland |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077550 | Ivabradine |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 6 months |
| Cardiovascular hospitalization | 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 |