Clinical trial NCT06082388: Atropine vs Isoprenaline in the Invasive Diagnosis of Arrhythmias
Official title: Comparison of the Clinical Utility of Atropine and Isoprenaline in the Invasive Diagnosis of Arrhythmias
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Arrhythmia
Supraventricular Arrhythmia
Keywords: Electrophysiological study
Atropine
Isoprenaline
Supraventricular arrhythmia
Ablation
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Evaluation of sino-atrial conduction time
timeFrame: During the procedure
measure: Evaluation of sinus node recovery time
timeFrame: During the procedure
measure: Evaluation of anterograde atrioventricular conduction
timeFrame: During the procedure
measure: Evaluation of retrograde atrioventricular conduction
timeFrame: During the procedure
measure: Arrhythmia inducibility
timeFrame: During the procedure
measure: Long-term success rate
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of adverse events during the electrophysiological study.
timeFrame: During the procedure
measure: Incidence of adverse events during the 12-month follow up.
timeFrame: 12 months
measure: Length of the procedure
timeFrame: During the procedure
measure: Procedure time form drug administration till the end.
timeFrame: During the procedure
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Electrocardiology Medical University of Lodz
Study officials:
References:
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:1013258331023.
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 Heart J. 1989 Mar;61(3):268-73. doi: 10.1136/hrt.61.3.268.
citation: 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.