Policlinico Casilino
Rome, 00169, Italy
NCT Number: NCT01657136
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Rome, 00169, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
comparison of different drugs
comparison of different drugs
Time frame: three months
Percentage of HR reduction at Holter ECG (mean, minimal and maximal)
Time frame: three months
Percentage of maximal HR reduction at stress-test ECG
Time frame: three months
Improvement of stress-tolerance (maximal load reached at stress test ECG)
Time frame: three months
Improvement of the quality of life (Minnesota QoL questionnaire)
Policlinico Casilino ASL RMB
Other
Comparison of Ivabradine and Beta-blockers Administration in the Treatment of Inappropriate Sinus Tachycardia
Acronym: CIBIST
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