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
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Condition or disease | Intervention/treatment | Phase |
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Inappropriate Sinus Tachycardia | Drug: Ivabradine Drug: Beta blocker | Phase 3 |
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 |
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).
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Drug: Ivabradine
comparison of different drugs
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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).
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Drug: Beta blocker
comparison of different drugs
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- 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
- 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)

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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;

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
Italy | |
Policlinico Casilino | |
Rome, Italy, 00169 |
Principal Investigator: | Leonardo Calò, FESC MD | Policlinico Casilino |
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 |