Atropine vs Isoprenaline in the Invasive Diagnosis of Arrhythmias

Sponsor
Medical University of Lodz (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06082388
Collaborator
(none)
200
1
2
24.7
8.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Comparison of atropine and isoprenaline
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparison of the Clinical Utility of Atropine and Isoprenaline in the Invasive Diagnosis of Arrhythmias
Anticipated Study Start Date :
Nov 9, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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

Active Comparator: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of sino-atrial conduction time [During the procedure]

    Sino-atrial conduction time (ms) during programed atrial stimulation will be assessed to examine the function of sinus node.

  2. Evaluation of sinus node recovery time [During the procedure]

    Sinus node recovery time (ms) during programed atrial stimulation will be assessed to examine the function of sinus node.

  3. Evaluation of anterograde atrioventricular conduction [During the procedure]

    Anterograde Wenkebach point (ms) and effective refractory period of atrioventricular node (ms) during programed atrial stimulation will be assessed.

  4. Evaluation of retrograde atrioventricular conduction [During the procedure]

    Retrograde Wenkebach point (ms) and effective refractory period of atrioventricular node (ms) during programed ventricular stimulation will be assessed.

  5. Arrhythmia inducibility [During the procedure]

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

  6. Long-term success rate [12 months]

    Recurrence of clinical arrhythmia during 12 months of observation

Secondary Outcome Measures

  1. Incidence of adverse events during the electrophysiological study. [During the procedure]

    Analysis of adverse events during the electrophysiological study according to used drug. Adverse events includes: death, stroke, cardiogenic shock, anaphylaxis, myocardial infarction, electric storm.

  2. Incidence of adverse events during the 12-month follow up. [12 months]

    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.

  3. Length of the procedure [During the procedure]

    Analysis of the whole procedure time according to used drug.

  4. Procedure time form drug administration till the end. [During the procedure]

    Analysis of the procedure time form atropine/isoprenaline administration till the end.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Electrocardiology Medical University of Lodz Lodz Poland 93-216

Sponsors and Collaborators

  • Medical University of Lodz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medical University of Lodz
ClinicalTrials.gov Identifier:
NCT06082388
Other Study ID Numbers:
  • RNN/327/20/KE
First Posted:
Oct 13, 2023
Last Update Posted:
Oct 13, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Medical University of Lodz
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2023