CIBIST
Comparison of Ivabradine and Beta-blockers Administration in the Treatment of Inappropriate Sinus Tachycardia
Sponsor study identifier
Secondary identifiers
interventional
20
1 country
1
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2016
Actual (reported)Study Completion
September 2016
Actual (reported)The aim of this study is to prospectively compare the effectiveness and safety of ivabradine and beta-blockers in the treatment of inappropriate sinus tachycardia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 30, 2012
Actual (reported)August 6, 2012
Actual (reported)September 2013
Date type not reportedThis date has not been verified as actual or estimated.
September 2016
Actual (reported)September 2016
Actual (reported)heart rate reduction
Percentage of HR reduction at Holter ECG (mean, minimal and maximal)
three months
heart rate reduction
Percentage of maximal HR reduction at stress-test ECG
three months
physical tolerance and quality of life
three months
physical tolerance and quality of life
three months
Ivabradine will be initiated at a dose of 5 mg twice daily. Dosage should be augmented up to 7.5 mg twice daily in case of symptoms persistence and/or HR \> 85 bpm at rest ECG and eventually lowered up to 2.5 mg twice daily in the presence of side effects (phosphenes, diplopia and symptomatic bradycardia).
Bisoprololo will be initiated at a single dose of 5 mg daily. Dosage should be augmented up to 10 mg single dose daily in case of symptoms persistence and/or HR \> 85 bpm at rest ECG and eventually lowered up to 2,5 mg single dose daily in the presence of side effects (symptomatic bradycardia, hypotension).
comparison of different drugs
comparison of different drugs
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Policlinico Casilino
Rome, Rome, 00169, Italy
Calo L, Rebecchi M, Sette A, Martino A, de Ruvo E, Sciarra L, De Luca L, Zuccaro LM, Giunta G, Ciccaglioni A, Lioy E, Fedele F. Efficacy of ivabradine administration in patients affected by inappropriate sinus tachycardia. Heart Rhythm. 2010 Sep;7(9):1318-23. doi: 10.1016/j.hrthm.2010.05.034. Epub 2010 Jun 1.
Ptaszynski P, Kaczmarek K, Ruta J, Klingenheben T, Wranicz JK. Metoprolol succinate vs. ivabradine in the treatment of inappropriate sinus tachycardia in patients unresponsive to previous pharmacological therapy. Europace. 2013 Jan;15(1):116-21. doi: 10.1093/europace/eus204. Epub 2012 Jul 6.
Leonardo Calò, FESC MD
Policlinico Casilino
20 participants (actual enrollment reported by the registry).
First Submitted
July 30, 2012
First Posted
August 6, 2012
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
HEAL-IST IDE Trial
Contact the study team to confirm eligibility.
Primary Completion
September 2016
Actual (reported)Study Completion
September 2016
Actual (reported)Last Updated
September 30, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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