Atropine vs Isoprenaline in the Invasive Diagnosis of Arrhythmias

Cardiac Arrhythmia Clinical Trial

Official title:

Comparison of the Clinical Utility of Atropine and Isoprenaline in the Invasive Diagnosis of Arrhythmias

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06082388
• Other study ID #: RNN/327/20/KE
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 9, 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Medical University of Lodz
• Contact: Krzysztof Kaczmarek, MD, PhD
• Phone: +48 42 201 43 60
• Email: krzysztof.kaczmarek[@]umed.lodz.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

During electrophysiological study (EPS) multiple drugs are used to reveal arrhythmias and/or conductive system disorders. Two most often used agents are atropine and isoprenaline. Due to their distinct pharmacological properties, they are affecting myocardium in different manner. Those dissimilarities can affect the EPS course and long-term prognosis. The aim of presented study is to evaluate the optimal protocol of pharmacotherapy during EPS.

Description:

Electrophysiological study (EPS) is essential tool for heart rhythm disorders diagnostic. Inducibility of arrhythmia before ablation to confirm the diagnosis and inability to do so after the procedure is crucial for long-term success. Multiple drugs are used to reveal arrhythmias and/or conductive system disorders. Two most often used are atropine and isoprenaline. Atropine is a natural, selective antagonist of cholinergic receptors M1 and M2. It reverses the inhibitory effect of vagal nerve on myocardium. This improves sinus node automatism and conduction in atrioventricular node. Isoprenaline is a preferential agonist of beta-1-adrenergic receptors. It has bathmotropic and chronotropic effect. During daily clinical practice those two drugs are often used interchangeably. However, differences in pharmacokinetics and pharmacodynamics may affect the results. There are lack of data directly comparing those two agents. There are isolated evidences that arrhythmia inducibility rate after the ablation differs between those two drugs. This may lead to the misconception of ablation as successful. The aim of presented study is to evaluate the optimal protocol of pharmacotherapy during EPS.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with indication for electrophysiological study according to present guidelines of European Society of Cardiology

Exclusion Criteria:

• Not willing or incapable to give written informed consent.
• Previous diagnosed ventricle tachycardia or fibrillation
• Previous diagnosed atrial fibrillation or flutter
• Glaucoma (contraindication for atropine)

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Supraventricular Arrhythmia

Intervention

Drug:
• Comparison of atropine and isoprenaline
Comparison of heart conductive system and arrhythmia inducibility after using atropine or isoprenaline

Locations

Country	Name	City	State
Poland	Department of Electrocardiology Medical University of Lodz	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lodz

Country where clinical trial is conducted

Poland, 

References & Publications (3)

Hatzinikolaou H, Rodriguez LM, Smeets JL, Timmermans C, Vrouchos G, Grecas G, Wellens HJ. Isoprenaline and inducibility of atrioventricular nodal re-entrant tachycardia. Heart. 1998 Feb;79(2):165-8. doi: 10.1136/hrt.79.2.165. — View Citation

Stellbrink C, Diem B, Schauerte P, Brehmer K, Schuett H, Hanrath P. Differential effects of atropine and isoproterenol on inducibility of atrioventricular nodal reentrant tachycardia. J Interv Card Electrophysiol. 2001 Dec;5(4):463-9. doi: 10.1023/a:10132 — View Citation

Toda I, Kawahara T, Murakawa Y, Nozaki A, Kawakubo K, Inoue H, Sugimoto T. Electrophysiological study of young patients with exercise related paroxysms of palpitation: role of atropine and isoprenaline for initiation of supraventricular tachycardia. Br He — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of sino-atrial conduction time	Sino-atrial conduction time (ms) during programed atrial stimulation will be assessed to examine the function of sinus node.	During the procedure
Primary	Evaluation of sinus node recovery time	Sinus node recovery time (ms) during programed atrial stimulation will be assessed to examine the function of sinus node.	During the procedure
Primary	Evaluation of anterograde atrioventricular conduction	Anterograde Wenkebach point (ms) and effective refractory period of atrioventricular node (ms) during programed atrial stimulation will be assessed.	During the procedure
Primary	Evaluation of retrograde atrioventricular conduction	Retrograde Wenkebach point (ms) and effective refractory period of atrioventricular node (ms) during programed ventricular stimulation will be assessed.	During the procedure
Primary	Arrhythmia inducibility	Inducibility of anticipated arrythmia before and after drug administration and after eventual ablation.	During the procedure
Primary	Long-term success rate	Recurrence of clinical arrhythmia during 12 months of observation	12 months
Secondary	Incidence of adverse events during the electrophysiological study.	Analysis of adverse events during the electrophysiological study according to used drug. Adverse events includes: death, stroke, cardiogenic shock, anaphylaxis, myocardial infarction, electric storm.	During the procedure
Secondary	Incidence of adverse events during the 12-month follow up.	Analysis of adverse events during the 12-month follow up according to used drug. Adverse events includes: death, stroke, cardiogenic shock, anaphylaxis, myocardial infarction, electric storm.	12 months
Secondary	Length of the procedure	Analysis of the whole procedure time according to used drug.	During the procedure
Secondary	Procedure time form drug administration till the end.	Analysis of the procedure time form atropine/isoprenaline administration till the end.	During the procedure