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

Policlinico Casilino ASL RMB

Status and phase: Completed; Phase 3

Conditions: Inappropriate Sinus Tachycardia

Treatments: Drug: Ivabradine; Drug: Beta blocker

Study type: Interventional

Funder types: Other

Identifiers

NCT01657136

0001

Casilino0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Ivabradine

Active Comparator group

Description:

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).

Treatment:

Drug: Ivabradine

Beta blocker (Bisoprololo)

Active Comparator group

Description:

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).

Treatment:

Drug: Beta blocker