A Phase 4 interventional study of Ivabradine in Heart Failure, sponsored by Medical University of Warsaw. Status unknown at 1 site in Poland. Per ClinicalTrials.gov, last updated 2014-06-18.
Sponsored by Medical University of Warsaw · Phase 4, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ivabradine 5 mg twice a day or 7,5 mg twice a day
Drug: Ivabradine
Ivabradine 5 mg twice a day or 7,5 mg twice a day
Also known as: Procoralan
Percentage of biventricular pacing >95%
Time frame: 6 months
Percentage of biventricular pacing >98%
Time frame: 6 months
Time to first inappropriate shock
Time frame: 6 months
change of mean heart rate compared with baseline
Time frame: 6 months
Cardiovascular hospitalization
Time frame: 6 months
The change between baseline and final echocardiographic parameters
Time frame: 6 months
The assessment of quality of life (SF36)
Time frame: 6 months
The change between baseline and final NYHA class
Time frame: 6 months
Number of participants with adverse events
Time frame: 6 months
This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw