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Completed

NCT Number: NCT01657136

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Policlinico Casilino

Rome, 00169, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Ivabradine

Drug

comparison of different drugs

Beta blocker

Drug

comparison of different drugs

Primary outcomes

  1. heart rate reduction

    Time frame: three months

    Percentage of HR reduction at Holter ECG (mean, minimal and maximal)

  2. heart rate reduction

    Time frame: three months

    Percentage of maximal HR reduction at stress-test ECG

Secondary outcomes

  1. physical tolerance and quality of life

    Time frame: three months

    Improvement of stress-tolerance (maximal load reached at stress test ECG)

  2. physical tolerance and quality of life

    Time frame: three months

    Improvement of the quality of life (Minnesota QoL questionnaire)

Sponsors and collaborators

Lead sponsor

Policlinico Casilino ASL RMB

Other

Registry information

Official study title

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

Acronym: CIBIST

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 6, 2012
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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