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

Inappropriate Sinus Tachycardia Clinical Trial

— CIBIST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657136
• Other study ID #: Casilino0001
• Secondary ID: 0001
• Status: Completed
• Phase: Phase 3
• First received: July 30, 2012
• Last updated: September 29, 2016
• Start date: September 2013
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Policlinico Casilino ASL RMB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inappropriate Sinus Tachycardia
• Tachycardia
• Tachycardia, Sinus

Intervention

Drug:
• Ivabradine
comparison of different drugs
• Beta blocker
comparison of different drugs

Locations

Country	Name	City	State
Italy	Policlinico Casilino	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Casilino ASL RMB

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Calò L, Rebecchi M, Sette A, Martino A, de Ruvo E, Sciarra L, De Luca L, Zuccaro LM, Giunta G, Ciccaglioni A, Lioy E, Fedele F. Efficacy of ivabradine administration in patients affected by inappropriate sinus tachycardia. Heart Rhythm. 2010 Sep;7(9):1318-23. doi: 10.1016/j.hrthm.2010.05.034. Epub 2010 Jun 1. — View Citation

Ptaszynski P, Kaczmarek K, Ruta J, Klingenheben T, Wranicz JK. Metoprolol succinate vs. ivabradine in the treatment of inappropriate sinus tachycardia in patients unresponsive to previous pharmacological therapy. Europace. 2013 Jan;15(1):116-21. doi: 10.1093/europace/eus204. Epub 2012 Jul 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate reduction	Percentage of HR reduction at Holter ECG (mean, minimal and maximal)	three months	No
Primary	heart rate reduction	Percentage of maximal HR reduction at stress-test ECG	three months	No
Secondary	physical tolerance and quality of life	Improvement of stress-tolerance (maximal load reached at stress test ECG)	three months	No
Secondary	physical tolerance and quality of life	Improvement of the quality of life (Minnesota QoL questionnaire)	three months	No