Atropine vs Isoprenaline in the Invasive Diagnosis of Arrhythmias

NCT ID: NCT06082388

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-09
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Cardiac Arrhythmia; Supraventricular Arrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Atropine

Patients in whom during electrophysiological study atropine will be used. I.v. bolus of 0.01 mg/kg b.w. will be administered to reach the increase of heart rate of 25% or up to 130/min. If necessary, dose will be increased every 5 minutes until mention above parameters are achieved. Maximum dose will be 0.4 mg/kg b.w.

Group Type: ACTIVE_COMPARATOR

Comparison of atropine and isoprenaline

Intervention Type: DRUG

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

Isoprenaline

Patients in whom during electrophysiological study isoprenaline will be used. Continuous i.v. infusion of 0.01 mcg/kg b.w./min will be administered to reach the increase of heart rate of 25% or up to 130/min. If necessary, dose will be doubled every 5 minutes until mention above parameters are achieved. Maximum dose will be 20 mcg/min.

Group Type: ACTIVE_COMPARATOR

Comparison of atropine and isoprenaline

Intervention Type: DRUG

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

Interventions

Comparison of atropine and isoprenaline

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Electrocardiology Medical University of Lodz

Lodz, , Poland

Countries

Poland

Central Contacts

Krzysztof Kaczmarek, MD, PhD

Role: CONTACT

krzysztof.kaczmarek@umed.lodz.pl

+48 42 201 43 60

References

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:1013258331023.

Reference Type: RESULT

PMID: 11752915 (View on PubMed)

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 Heart J. 1989 Mar;61(3):268-73. doi: 10.1136/hrt.61.3.268.

Reference Type: RESULT

PMID: 2930664 (View on PubMed)

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.

Reference Type: RESULT

PMID: 9538310 (View on PubMed)

Other Identifiers

RNN/327/20/KE

Identifier Type: -

Identifier Source: org_study_id