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

Study Overview
=================
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.

Official Title
-----------------
Comparison of Ivabradine and Beta-blockers Administration in the Treatment of Inappropriate Sinus Tachycardia

Conditions
-----------------
Inappropriate Sinus Tachycardia

Intervention / Treatment
-----------------
* Drug: Ivabradine
* Drug: Beta blocker


Participation Criteria
=================
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ivabradine<br>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<br>* comparison of different drugs<br>|
| Active Comparator: Beta blocker (Bisoprololo)<br>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). | Drug: Beta blocker<br>* comparison of different drugs<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate reduction | Percentage of HR reduction at Holter ECG (mean, minimal and maximal) | three months | 
| heart rate reduction | Percentage of maximal HR reduction at stress-test ECG | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical tolerance and quality of life | Improvement of stress-tolerance (maximal load reached at stress test ECG) | three months | 
| physical tolerance and quality of life | Improvement of the quality of life (Minnesota QoL questionnaire) | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inappropriate sinus tachycardia, ivabradine, beta blockers