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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01657136

Acronym

CIBIST

Enrollment

Registered

2012-08-06

Start date

2013-09-30

Completion date

2016-09-30

Last updated

2016-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inappropriate Sinus Tachycardia

Keywords

Inappropriate sinus tachycardia, ivabradine, beta blockers

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.

Interventions

DRUGIvabradine

comparison of different drugs

DRUGBeta blocker

comparison of different drugs

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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;

Design outcomes

Primary

Measure	Time frame	Description
heart rate reduction	three months	Percentage of HR reduction at Holter ECG (mean, minimal and maximal)

Secondary

Measure	Time frame	Description
physical tolerance and quality of life	three months	Improvement of stress-tolerance (maximal load reached at stress test ECG)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026