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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

July 30, 2012
August 6, 2012
September 30, 2016
September 2013
September 2016   (Final data collection date for primary outcome measure)
  • heart rate reduction [ Time Frame: three months ]
    Percentage of HR reduction at Holter ECG (mean, minimal and maximal)
  • heart rate reduction [ Time Frame: three months ]
    Percentage of maximal HR reduction at stress-test ECG
Same as current
Complete list of historical versions of study NCT01657136 on ClinicalTrials.gov Archive Site
  • physical tolerance and quality of life [ Time Frame: three months ]
    Improvement of stress-tolerance (maximal load reached at stress test ECG)
  • physical tolerance and quality of life [ Time Frame: three months ]
    Improvement of the quality of life (Minnesota QoL questionnaire)
Same as current
Not Provided
Not Provided
 
Ivabradine Versus Beta-blockers in the Treatment of Inappropriate Sinus Tachycardia
Comparison of Ivabradine and Beta-blockers Administration in the Treatment of Inappropriate Sinus Tachycardia
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.
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.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Inappropriate Sinus Tachycardia
  • Drug: Ivabradine
    comparison of different drugs
  • Drug: Beta blocker
    comparison of different drugs
  • 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).
    Intervention: Drug: Ivabradine
  • 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).
    Intervention: Drug: Beta blocker

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Same as current
September 2016
September 2016   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01657136
Casilino0001
0001
No
Not Provided
Not Provided
Leonardo Calo, Policlinico Casilino ASL RMB
Policlinico Casilino ASL RMB
Not Provided
Principal Investigator: Leonardo Calò, FESC MD Policlinico Casilino
Policlinico Casilino ASL RMB
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP