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Atropine vs Isoprenaline in the Invasive Diagnosis of Arrhythmias

Primary Purpose

Cardiac Arrhythmia, Supraventricular Arrhythmia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Comparison of atropine and isoprenaline
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrhythmia focused on measuring Electrophysiological study, Atropine, Isoprenaline, Supraventricular arrhythmia, Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Electrocardiology Medical University of Lodz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Atropine

Isoprenaline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Evaluation of anterograde atrioventricular conduction
Anterograde Wenkebach point (ms) and effective refractory period of atrioventricular node (ms) during programed atrial stimulation will be assessed.
Evaluation of retrograde atrioventricular conduction
Retrograde Wenkebach point (ms) and effective refractory period of atrioventricular node (ms) during programed ventricular stimulation will be assessed.
Arrhythmia inducibility
Inducibility of anticipated arrythmia before and after drug administration and after eventual ablation.
Long-term success rate
Recurrence of clinical arrhythmia during 12 months of observation

Secondary Outcome Measures

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.
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.
Length of the procedure
Analysis of the whole procedure time according to used drug.
Procedure time form drug administration till the end.
Analysis of the procedure time form atropine/isoprenaline administration till the end.

Full Information

First Posted
January 12, 2022
Last Updated
October 9, 2023
Sponsor
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT06082388
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 9, 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lodz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmia, Supraventricular Arrhythmia
Keywords
Electrophysiological study, Atropine, Isoprenaline, Supraventricular arrhythmia, Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krzysztof Kaczmarek, MD, PhD
Phone
+48 42 201 43 60
Email
krzysztof.kaczmarek@umed.lodz.pl
Facility Information:
Facility Name
Department of Electrocardiology Medical University of Lodz
City
Lodz
ZIP/Postal Code
93-216
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11752915
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.
Results Reference
result
PubMed Identifier
2930664
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.
Results Reference
result
PubMed Identifier
9538310
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.
Results Reference
result

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Atropine vs Isoprenaline in the Invasive Diagnosis of Arrhythmias

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