Clinical trial NCT01657136: Ivabradine Versus Beta-blockers in the Treatment of Inappropriate Sinus Tachycardia
Official title: Comparison of Ivabradine and Beta-blockers Administration in the Treatment of Inappropriate Sinus Tachycardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inappropriate Sinus Tachycardia
Keywords: Inappropriate sinus tachycardia
ivabradine
beta blockers
Lead sponsor: Policlinico Casilino ASL RMB
Sponsor class: OTHER
First posted: 2012-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: heart rate reduction
timeFrame: three months
measure: heart rate reduction
timeFrame: three months
Secondary outcomes:
measure: physical tolerance and quality of life
timeFrame: three months
measure: physical tolerance and quality of life
timeFrame: three months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Casilino
Study officials:
affiliation: Policlinico Casilino
name: Leonardo Calò, FESC MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calo 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.
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.