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

Primary Purpose

Inappropriate Sinus Tachycardia

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Ivabradine
Beta blocker
Sponsored by
Policlinico Casilino ASL RMB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inappropriate Sinus Tachycardia focused on measuring Inappropriate sinus tachycardia, ivabradine, beta blockers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Policlinico Casilino

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ivabradine

Beta blocker (Bisoprololo)

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

heart rate reduction
Percentage of HR reduction at Holter ECG (mean, minimal and maximal)
heart rate reduction
Percentage of maximal HR reduction at stress-test ECG

Secondary Outcome Measures

physical tolerance and quality of life
Improvement of stress-tolerance (maximal load reached at stress test ECG)
physical tolerance and quality of life
Improvement of the quality of life (Minnesota QoL questionnaire)

Full Information

First Posted
July 30, 2012
Last Updated
September 29, 2016
Sponsor
Policlinico Casilino ASL RMB
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1. Study Identification

Unique Protocol Identification Number
NCT01657136
Brief Title
Ivabradine Versus Beta-blockers in the Treatment of Inappropriate Sinus Tachycardia
Acronym
CIBIST
Official Title
Comparison of Ivabradine and Beta-blockers Administration in the Treatment of Inappropriate Sinus Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Casilino ASL RMB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inappropriate Sinus Tachycardia
Keywords
Inappropriate sinus tachycardia, ivabradine, beta blockers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ivabradine
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Beta blocker (Bisoprololo)
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ivabradine
Intervention Description
comparison of different drugs
Intervention Type
Drug
Intervention Name(s)
Beta blocker
Intervention Description
comparison of different drugs
Primary Outcome Measure Information:
Title
heart rate reduction
Description
Percentage of HR reduction at Holter ECG (mean, minimal and maximal)
Time Frame
three months
Title
heart rate reduction
Description
Percentage of maximal HR reduction at stress-test ECG
Time Frame
three months
Secondary Outcome Measure Information:
Title
physical tolerance and quality of life
Description
Improvement of stress-tolerance (maximal load reached at stress test ECG)
Time Frame
three months
Title
physical tolerance and quality of life
Description
Improvement of the quality of life (Minnesota QoL questionnaire)
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Calò, FESC MD
Organizational Affiliation
Policlinico Casilino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Casilino
City
Rome
ZIP/Postal Code
00169
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20621618
Citation
Calo 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.
Results Reference
background
PubMed Identifier
22772053
Citation
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.
Results Reference
background

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

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