Ivabradine Versus Beta-blockers in the Treatment of Inappropriate Sinus Tachycardia (CIBIST)

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Inappropriate Sinus Tachycardia	Drug: Ivabradine; Drug: Beta blocker	Phase 3

Detailed Description:

Inappropriate sinus tachycardia (IST) is a non-paroxysmal arrhythmia, characterized by a persistently high sinus heart rate (HR) and/or an exaggerated HR response to minimal exertion, and can be responsible for palpitations, asthenia, chest pain, dizziness and syncope, which can be highly invalidating. Conventional treatment of IST, targeted to symptoms control, mainly consists on β-blockers. However, these drugs are often insufficient or not well tolerated because of side effects (mostly hypotension) that usually limit the administered dose. Ivabradine, a sinus rate lowering agent currently employed in Europe in the treatment of stable angina and chronic heart failure, has recently been demonstrated to be effective and safe in the treatment of IST by a few case reports and clinical trials. A randomized clinical trial comparing ivabradine to β-blockers has not be performed yet.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Comparison of Ivabradine and Beta-blockers Administration in the Treatment of Inappropriate Sinus Tachycardia
Study Start Date :	September 2013
Actual Primary Completion Date :	September 2016
Actual Study Completion Date :	September 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Ivabradine; 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).	Drug: Ivabradine; comparison of different drugs
Active Comparator: Beta blocker (Bisoprololo); 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).	Drug: Beta blocker; comparison of different drugs

Outcome Measures

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Primary Outcome Measures :

1. heart rate reduction [ Time Frame: three months ]
   Percentage of HR reduction at Holter ECG (mean, minimal and maximal)
2. heart rate reduction [ Time Frame: three months ]
   Percentage of maximal HR reduction at stress-test ECG

Secondary Outcome Measures :

1. physical tolerance and quality of life [ Time Frame: three months ]
   Improvement of stress-tolerance (maximal load reached at stress test ECG)
2. physical tolerance and quality of life [ Time Frame: three months ]
   Improvement of the quality of life (Minnesota QoL questionnaire)

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Inappropriate sinus tachycardia (HR >100 bpm at rest ECG and/or medium Holter ECG HR >90 bpm)
• Age > 18 years;

Exclusion Criteria:

• Secondary causes of sinus tachycardia;
• Structural heart diseases,
• Postural orthostatic tachycardia syndrome;
• Sinus nodal reentrant tachycardia;
• Contraindications to beta-blockers;
• Administration of beta-blockers, non-di-hydropiridinic calcium channels antagonists, class I and III anti-arrhythmic drugs or digitalis at the time of enrollment;
• Age < 18 years;
• Inability of giving informed consent;

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Italy
Policlinico Casilino
Rome, Italy, 00169

Sponsors and Collaborators

Policlinico Casilino ASL RMB

Investigators

Principal Investigator:	Leonardo Calò, FESC MD	Policlinico Casilino

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Calò 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.

Responsible Party:	Leonardo Calo, Director of clinical arrhythmology and cardiac electrophysiology department, Policlinico Casilino ASL RMB
ClinicalTrials.gov Identifier:	NCT01657136 History of Changes
Other Study ID Numbers:	Casilino0001; 0001
First Posted:	August 6, 2012
Last Update Posted:	September 30, 2016
Last Verified:	September 2016

Keywords provided by Leonardo Calo, Policlinico Casilino ASL RMB:

Inappropriate sinus tachycardia; ivabradine; beta blockers

Additional relevant MeSH terms:

Tachycardia; Tachycardia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Tachycardia, Supraventricular	Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs