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

This study is currently recruiting participants. (see Contacts and Locations)

Verified November 2014 by Policlinico Casilino ASL RMB

Sponsor:

Information provided by (Responsible Party):

Leonardo Calo, Policlinico Casilino ASL RMB

ClinicalTrials.gov Identifier:

NCT01657136

First received: July 30, 2012

Last updated: November 4, 2014

Last verified: November 2014

History of Changes

Purpose

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	Intervention	Phase
Inappropriate Sinus Tachycardia	Drug: Ivabradine Drug: Beta blocker	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of Ivabradine and Beta-blockers Administration in the Treatment of Inappropriate Sinus Tachycardia

Resource links provided by NLM:

Drug Information available for: Adrenergic beta-Antagonists

U.S. FDA Resources

Further study details as provided by Policlinico Casilino ASL RMB:

Primary Outcome Measures:

heart rate reduction [ Time Frame: three months ] [ Designated as safety issue: No ]
Percentage of HR reduction at Holter ECG (mean, minimal and maximal)
heart rate reduction [ Time Frame: three months ] [ Designated as safety issue: No ]
Percentage of maximal HR reduction at stress-test ECG

Secondary Outcome Measures:

physical tolerance and quality of life [ Time Frame: three months ] [ Designated as safety issue: No ]
Improvement of stress-tolerance (maximal load reached at stress test ECG)
physical tolerance and quality of life [ Time Frame: three months ] [ Designated as safety issue: No ]
Improvement of the quality of life (Minnesota QoL questionnaire)


Estimated Enrollment:	20
Study Start Date:	September 2013
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657136

Contacts


Contact: Leonardo Calò, FESC MD	00390623188406	leonardo.calo@tin.it

Locations


Italy
Policlinico Casilino	Recruiting
Rome, Italy, 00169
Contact: Calo' Leonardo, MD 0039-06-23188406 leonardo.calo@tin.it

Sponsors and Collaborators

Policlinico Casilino ASL RMB

Investigators


Principal Investigator:	Leonardo Calò, FESC MD	Policlinico Casilino

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
Study First Received:	July 30, 2012
Last Updated:	November 4, 2014
Health Authority:	Italy: Ethics Committee

Keywords provided by Policlinico Casilino ASL RMB:


Inappropriate sinus tachycardia ivabradine beta blockers

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 27, 2015

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