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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 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 13, 2013
Last verified: November 2013
  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

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: December 2014
Estimated Primary Completion Date: April 2014 (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:
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 13, 2013
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
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Tachycardia, Supraventricular
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014