Atropine vs Isoprenaline in the Invasive Diagnosis of Arrhythmias

NCT06082388 | Unknown DMC

• 1 other identifier: RNN/327/20/KE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrhythmia; Supraventricular Arrhythmia

Keywords

Electrophysiological study; Atropine; Isoprenaline; Supraventricular arrhythmia; Ablation

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• Arrhythmia inducibility

  Inducibility of anticipated arrythmia before and after drug administration and after eventual ablation.

  During the procedure

• Long-term success rate

  Recurrence of clinical arrhythmia during 12 months of observation

  12 months

Secondary Outcomes (4)

• Incidence of adverse events during the electrophysiological study.

  During the procedure

• Incidence of adverse events during the 12-month follow up.

  12 months

• Length of the procedure

  During the procedure

• Procedure time form drug administration till the end.

  During the procedure

Study Arms (2)

Atropine

ACTIVE COMPARATOR

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.

Drug: Comparison of atropine and isoprenaline

Isoprenaline

ACTIVE COMPARATOR

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.

Drug: Comparison of atropine and isoprenaline

Interventions

Comparison of atropine and isoprenaline DRUG

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

Atropine; Isoprenaline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Department of Electrocardiology Medical University of Lodz

Lodz, 93-216, Poland

Location

Related Publications (3)

• 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.

  PMID: 11752915 RESULT

• 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.

  PMID: 2930664 RESULT

• 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.

  PMID: 9538310 RESULT

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Isoproterenol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Krzysztof Kaczmarek, MD, PhD

CONTACT

+48 42 201 43 60; krzysztof.kaczmarek@umed.lodz.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: October 13, 2023
• Study Start: November 9, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

PL (1)