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

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ClinicalTrials.gov Identifier: NCT01657136
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Leonardo Calo, Policlinico Casilino ASL RMB

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

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Arms and Interventions
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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, Older Adult)
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657136


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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Publications:

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    Key Record Dates
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