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

Phase 3

Completed

• Conditions: Inappropriate Sinus Tachycardia
• Interventions: Drug: Beta blocker; Drug: Ivabradine

• Registration Number: NCT01657136
• Lead Sponsor: Policlinico Casilino ASL RMB

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.

Study Timeline

• Study First Submitted: 2012-07-30
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-06
• Study Start: 2013-09
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beta blocker (Bisoprololo)	Beta blocker	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).
Ivabradine	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).

Primary Outcome Measures

Name	Time	Method
heart rate reduction	three months	Percentage of maximal HR reduction at stress-test ECG

Secondary Outcome Measures

Name	Time	Method
physical tolerance and quality of life	three months	Improvement of the quality of life (Minnesota QoL questionnaire)

Trial Locations

Locations (1)

Policlinico Casilino; 🇮🇹 Rome, Italy