Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy
IvaCRT
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 heart-failure
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
June 18, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJune 18, 2014
June 1, 2014
2 years
June 10, 2014
June 13, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of biventricular pacing >95%
6 months
Secondary Outcomes (7)
Percentage of biventricular pacing >98%
6 months
Time to first inappropriate shock
6 months
change of mean heart rate compared with baseline
6 months
Cardiovascular hospitalization
6 months
The change between baseline and final echocardiographic parameters
6 months
- +2 more secondary outcomes
Other Outcomes (1)
Number of participants with adverse events
6 months
Study Arms (1)
Ivabradine
EXPERIMENTALIvabradine 5 mg twice a day or 7,5 mg twice a day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- persistent atrial fibrillation/flutter
- device associated ineffective resynchronization
- contraindications to ivabradine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1st Department of Cariology of Medcial University of Warsaw
Warsaw, Masovian Voivodeship, 02-097, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marcin Grabowski, MD
Medical University of Warsaw
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
June 10, 2014
First Posted
June 18, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
June 18, 2014
Record last verified: 2014-06