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Ivabradine Versus Beta-blockers in the Treatment of Inappropriate Sinus Tachycardia (CIBIST)
This study has been completed.
Sponsor:
Policlinico Casilino ASL RMB
Information provided by (Responsible Party):
Leonardo Calo, Policlinico Casilino ASL RMB
ClinicalTrials.gov Identifier:
NCT01657136
First received: July 30, 2012
Last updated: September 29, 2016
Last verified: September 2016
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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 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 |
Resource links provided by NLM:
Further study details as provided by Leonardo Calo, Policlinico Casilino ASL RMB:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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)
| Enrollment: | 20 |
| Study Start Date: | September 2013 |
| Study Completion Date: | September 2016 |
| Primary Completion Date: | September 2016 (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
|
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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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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 (Adult, Senior) |
| 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;
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01657136
Please refer to this study by its ClinicalTrials.gov identifier: 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
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: | September 29, 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 |
ClinicalTrials.gov processed this record on September 20, 2017