Cardiac ArrhythmiaNCT06082388
Atropine vs Isoprenaline in the Invasive Diagnosis of Arrhythmias
A study testing Comparison of atropine and isoprenaline in people with Cardiac Arrhythmia and Supraventricular Arrhythmia, run by Medical University of Lodz at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia, Supraventricular Arrhythmia
- What is being tested?
- Comparison of atropine and isoprenaline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 9 Nov 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with indication for electrophysiological study according to present guidelines of European Society of Cardiology
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Electrocardiology Medical University of Lodz
Lodz, 93-216
About this study
Official title: Comparison of the Clinical Utility of Atropine and Isoprenaline in the Invasive Diagnosis of Arrhythmias
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.
Read the 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
- Being tested
- Comparison of atropine and isoprenaline
- Keywords
- Electrophysiological study, Atropine, Isoprenaline, Supraventricular arrhythmia, Ablation
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of atropine and isoprenalineDrug
Comparison of heart conductive system and arrhythmia inducibility after using atropine or isoprenaline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Comparison of atropine and isoprenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the procedure
Arrhythmia inducibility
Inducibility of anticipated arrythmia before and after drug administration and after eventual ablation.
Measured: During the procedure
Long-term success rate
Recurrence of clinical arrhythmia during 12 months of observation
Measured: 12 months
Secondary outcomes (4)
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.
Measured: During the procedure
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.
Measured: 12 months
Length of the procedure
Analysis of the whole procedure time according to used drug.
Measured: During the procedure
Procedure time form drug administration till the end.
Analysis of the procedure time form atropine/isoprenaline administration till the end.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start9 Nov 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082388
- Sponsor's protocol ID
- RNN/327/20/KE
- Status last verified
- Oct 2023
- First submitted
- 12 Jan 2022
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11752915Toda 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.
PubMed 2930664Hatzinikolaou 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.
PubMed 9538310
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Utility of Atropine and Isoprenaline in the Invasive Diagnosis of Arrhythmias
- ClinicalTrials.gov ID
- NCT06082388
- Acronym / sponsor ID
- RNN/327/20/KE
- Conditions
- Cardiac Arrhythmia, Supraventricular Arrhythmia
- Keywords
- Electrophysiological study, Atropine, Isoprenaline, Supraventricular arrhythmia, Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 9 Nov 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine | Active comparator | Drug: Comparison of atropine and isoprenalinePatients 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. |
| Isoprenaline | Active comparator | Drug: Comparison of atropine and isoprenalinePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with indication for electrophysiological study according to present guidelines of European Society of Cardiology
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of atropine and isoprenalineComparison of heart conductive system and arrhythmia inducibility after using atropine or isoprenaline | Drug | Atropine, Isoprenaline |
Primary outcome
Evaluation of sino-atrial conduction time
Time frame: During the procedure
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
Time frame: During the procedure
Sinus node recovery time (ms) during programed atrial stimulation will be assessed to examine the function of sinus node.
Evaluation of anterograde atrioventricular conduction
Time frame: During the procedure
Anterograde Wenkebach point (ms) and effective refractory period of atrioventricular node (ms) during programed atrial stimulation will be assessed.
Evaluation of retrograde atrioventricular conduction
Time frame: During the procedure
Retrograde Wenkebach point (ms) and effective refractory period of atrioventricular node (ms) during programed ventricular stimulation will be assessed.
Arrhythmia inducibility
Time frame: During the procedure
Inducibility of anticipated arrythmia before and after drug administration and after eventual ablation.
Long-term success rate
Time frame: 12 months
Recurrence of clinical arrhythmia during 12 months of observation
4 secondary outcomes
Incidence of adverse events during the electrophysiological study.
Time frame: During the procedure
Incidence of adverse events during the 12-month follow up.
Time frame: 12 months
Length of the procedure
Time frame: During the procedure
Procedure time form drug administration till the end.
Time frame: During the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Results publication: PubMed 11752915Stellbrink 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 publication: PubMed 2930664Toda 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 publication: PubMed 9538310Hatzinikolaou 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of atropine and isoprenaline in people with Cardiac Arrhythmia and Supraventricular Arrhythmia, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krzysztof Kaczmarek, MD, PhD (+48 42 201 43 60, krzysztof.kaczmarek@umed.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of sino-atrial conduction time (time frame: During the procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06082388, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.