Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy
NCT ID: NCT02166060
Last Updated: 2014-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2014-08-31
2016-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ivabradine
Ivabradine 5 mg twice a day or 7,5 mg twice a day
Ivabradine
Ivabradine 5 mg twice a day or 7,5 mg twice a day
Interventions
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Ivabradine
Ivabradine 5 mg twice a day or 7,5 mg twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* device associated ineffective resynchronization
* contraindications to ivabradine
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Marcin Grabowski
PhD
Principal Investigators
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Marcin Grabowski, MD
Role: STUDY_CHAIR
Medical University of Warsaw
Locations
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1st Department of Cariology of Medcial University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Countries
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Central Contacts
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Other Identifiers
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IvaCRT KB/111/2014
Identifier Type: -
Identifier Source: org_study_id
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