Arrhythmias VentricularPhase 4AMIOLIDO-VTNCT03299517
PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT
A Phase 4 study testing Antiarrythmic Drugs and Antiarrhythmic drugs in people with Arrhythmias Ventricular, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Introduction: Recent studies have suggested that other medications may be superior to amiodarone in controlling ventricular arrhythmias. However, a prospective and randomized comparison with lidocaine has not yet been described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias Ventricular
- What is being tested?
- Antiarrythmic Drugs and Antiarrhythmic drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Aug 2017to 2 Aug 2022
- Phase
- Phase 4
- 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
- Adult men and women> 18 years old
- Presence of sustained ventricular tachycardia with HR> 120 bpm
- Systolic blood pressure> 90 mmHg
- No signs of poor peripheral perfusion
- Absence of dyspnea
- Absence of severe angina
- Signed consent form
Who cannot join
- Pregnancy
- Hemodynamic instability
- Body mass index greater than 40 kg / m2
- Use of intravenous amiodarone or lidocaine in the last 24 hours
- Acute coronary syndrome
- Presence of tachycardia with irregular or supraventricular RR
- Contraindications to study drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração - HMFMUSP
São Paulo, São Paulo, 05403000
Alexandre Soeiro, MD, 5511-2661-5299, alexandre.soeiro@bol.com.br
About this study
Official title: PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN PATIENTS WITH STABLE VENTRICULAR TACHYCARDIA IN THE EMERGENCY ROOM
Introduction: Recent studies have suggested that other medications may be superior to amiodarone in controlling ventricular arrhythmias. However, a prospective and randomized comparison with lidocaine has not yet been described.
Objective: This study aims to evaluate the effectiveness and safety of the use of amiodarone versus lidocaine in patients with stable ventricular tachycardias.
Read more
Methodology: For this, a unicentric, randomized and prospective study will be carried out, in which the two drugs will be administered in a comparative manner. Hospital data (test results, medical outcomes, arrhythmia reversal, complications) of patients will be analyzed for safety and effectiveness.
Expected results: The use of lidocaine is not inferior to amiodarone in the tolerability and reversion of stable ventricular tachycardias.
- Conditions
- Arrhythmias Ventricular
- Being tested
- Antiarrythmic Drugs, Antiarrhythmic drugs
- Keywords
- lidocaine, amiodarone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiarrythmic DrugsDrug
Also called lidocaine
Patient will be randomly randomized 1: 1 for the antiarrythmic drugs. If there is no reversal and there is no adverse event, a further dose of the same pre-administered medicinal product will be performed in another 30 minutes.
Antiarrhythmic drugsDrug
Also called amiodarone
Patient will be randomly randomized 1: 1 for the the antiarrythmic drugs. If there is no reversal and there is no adverse event, a further dose of the same pre-administered medicinal product will be performed in another 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Experimental | Initial dose: antiarrythmic drugs Lidocaine (1.5 mg / kg EV in 30 minutes).
Adittional dose: Lidocaine (0.75 mg / kg EV in 30 minutes). Receives: Drug: Antiarrythmic Drugs |
| amiodarone | Experimental | Initial dose: antiarrythmic drugs Amiodarone (5 mg / kg EV in 30 minutes)
Adittional dose: Amiodarone (3 mg / kg EV in 30 minutes) Receives: Drug: Antiarrhythmic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs of peripheral hypoperfusion and shock
hypoperfusion and shock
Measured: 1 hour
Signs of pulmonary congestion
dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry.
Measured: 1 hour
Severe hypotension
systolic blood pressure <70 mmHg if the previous one is <100 mmHg or systolic blood pressure <80 mmHg if the previous one is > 100 mmHg).
Measured: 1 hour
HR increase
HR increase> 20 bpm.
Measured: 1 hour
The appearance of polymorphic TV.
polymorphic TV.
Measured: 1 hour
Lowering the level of consciousness.
glasgow < 15
Measured: 1 hour
Secondary outcomes (2)
effectiveness of reversal
sinusal rhythm
Measured: 1 hour
time required for reversal
sinusal rhythm
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start2 Aug 2017
- Primary completion2 Aug 2019 (estimated)
- Study completion2 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arrhythmias VentricularStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Soeiro, MD, Principal investigator, Unidade Clínica de Emergência
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299517
- Sponsor's protocol ID
- PSInCor-AMIOLIDO-VT
- Acronym
- AMIOLIDO-VT
- Status last verified
- Oct 2018
- First submitted
- 27 Sep 2017
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Somberg JC, Bailin SJ, Haffajee CI, Paladino WP, Kerin NZ, Bridges D, Timar S, Molnar J; Amio-Aqueous Investigators. Intravenous lidocaine versus intravenous amiodarone (in a new aqueous formulation) for incessant ventricular tachycardia. Am J Cardiol. 2002 Oct 15;90(8):853-9. doi: 10.1016/s0002-9149(02)02707-8.
PubMed 12372573Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available.
PubMed 26472995
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN PATIENTS WITH STABLE VENTRICULAR TACHYCARDIA IN THE EMERGENCY ROOM
- ClinicalTrials.gov ID
- NCT03299517
- Acronym / sponsor ID
- AMIOLIDO-VT / PSInCor-AMIOLIDO-VT
- Conditions
- Arrhythmias Ventricular
- Keywords
- lidocaine, amiodarone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 2 Aug 2019 (estimated)
- Study completion
- 2 Aug 2022 (estimated)
- First posted
- 3 Oct 2017 (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.
Introduction: Recent studies have suggested that other medications may be superior to amiodarone in controlling ventricular arrhythmias. However, a prospective and randomized comparison with lidocaine has not yet been described.
Objective: This study aims to evaluate the effectiveness and safety of the use of amiodarone versus lidocaine in patients with stable ventricular tachycardias.
Methodology: For this, a unicentric, randomized and prospective study will be carried out, in which the two drugs will be administered in a comparative manner. Hospital data (test results, medical outcomes, arrhythmia reversal, complications) of patients will be analyzed for safety and effectiveness.
Expected results: The use of lidocaine is not inferior to amiodarone in the tolerability and reversion of stable ventricular tachycardias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Experimental | Drug: Antiarrythmic DrugsInitial dose: antiarrythmic drugs Lidocaine (1.5 mg / kg EV in 30 minutes). Adittional dose: Lidocaine (0.75 mg / kg EV in 30 minutes). |
| amiodarone | Experimental | Drug: Antiarrhythmic drugsInitial dose: antiarrythmic drugs Amiodarone (5 mg / kg EV in 30 minutes) Adittional dose: Amiodarone (3 mg / kg EV in 30 minutes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult men and women> 18 years old
- Presence of sustained ventricular tachycardia with HR> 120 bpm
- Systolic blood pressure> 90 mmHg
- No signs of poor peripheral perfusion
- Absence of dyspnea
Key exclusion criteria (7 listed)
- Pregnancy
- Hemodynamic instability
- Body mass index greater than 40 kg / m2
- Use of intravenous amiodarone or lidocaine in the last 24 hours
- Acute coronary syndrome
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 |
|---|---|---|
| Antiarrythmic DrugsAlso: lidocainePatient will be randomly randomized 1: 1 for the antiarrythmic drugs. If there is no reversal and there is no adverse event, a further dose of the same pre-administered medicinal product will be performed in another 30 minutes. | Drug | lidocaine |
| Antiarrhythmic drugsAlso: amiodaronePatient will be randomly randomized 1: 1 for the the antiarrythmic drugs. If there is no reversal and there is no adverse event, a further dose of the same pre-administered medicinal product will be performed in another 30 minutes. | Drug | amiodarone |
Primary outcome
Signs of peripheral hypoperfusion and shock
Time frame: 1 hour
hypoperfusion and shock
Signs of pulmonary congestion
Time frame: 1 hour
dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry.
Severe hypotension
Time frame: 1 hour
systolic blood pressure <70 mmHg if the previous one is <100 mmHg or systolic blood pressure <80 mmHg if the previous one is > 100 mmHg).
HR increase
Time frame: 1 hour
HR increase> 20 bpm.
The appearance of polymorphic TV.
Time frame: 1 hour
polymorphic TV.
Lowering the level of consciousness.
Time frame: 1 hour
glasgow < 15
2 secondary outcomes
effectiveness of reversal
Time frame: 1 hour
time required for reversal
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Results publication: PubMed 12372573Somberg JC, Bailin SJ, Haffajee CI, Paladino WP, Kerin NZ, Bridges D, Timar S, Molnar J; Amio-Aqueous Investigators. Intravenous lidocaine versus intravenous amiodarone (in a new aqueous formulation) for incessant ventricular tachycardia. Am J Cardiol. 2002 Oct 15;90(8):853-9. doi: 10.1016/s0002-9149(02)02707-8.
- Results publication: PubMed 26472995Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Arrhythmias Ventricular
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Recruiting
ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
Myocardial Infarction (MI), Sudden Cardiac Death Due to Cardiac Arrhythmia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
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.
Alexandre Soeiro, MD principal investigator
Unidade Clínica de Emergência
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antiarrythmic Drugs and Antiarrhythmic drugs in people with Arrhythmias Ventricular, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 7 inclusion and 7 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 24 Oct 2018. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alexandre Soeiro, MD (1126615299, alexandre.soeiro@bol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signs of peripheral hypoperfusion and shock (time frame: 1 hour). 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 NCT03299517, which also lists 2 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 24 Oct 2018.