Inappropriate Sinus Tachycardia Clinical Trial
— CIBISTOfficial title:
Comparison of Ivabradine and Beta-blockers Administration in the Treatment of Inappropriate Sinus Tachycardia
Verified date | September 2016 |
Source | Policlinico Casilino ASL RMB |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
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; |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Casilino | Rome |
Lead Sponsor | Collaborator |
---|---|
Policlinico Casilino ASL RMB |
Italy,
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
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 |
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