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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01657136
Study type Interventional
Source Policlinico Casilino ASL RMB
Contact
Status Completed
Phase Phase 3
Start date September 2013
Completion date September 2016

See also
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Recruiting NCT02018497 - Essential Hypotension and Allostasis Registry
Withdrawn NCT01695538 - Yoga and Rate and Duration of Inappropriate Sinus Tachycardia (IST) Episodes N/A
Terminated NCT00584649 - Ablation of Inappropriate Sinus Tachycardia N/A