Clinical trial • Phase IV • Cardiology

Bupivacaine hydrochloride for Electrical storm

Phase IV trial of Bupivacaine hydrochloride for Electrical storm.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Electrical storm
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
04-08-2025
First CTIS Authorization Date
25-11-2025

Trial design

Randomised, amiodarone hikma 50 mg/ml soluzione iniettabile (amiodarone hydrochloride) — comparator (intravenous injection). dosing details not specified in the trial summary; product smpc metadata lists a max daily dose amount of 1200 mg.-controlled Phase IV trial across 13 sites in Italy.

Randomised
Yes
Comparator
Amiodarone Hikma 50 mg/ml soluzione iniettabile (Amiodarone hydrochloride) — comparator (intravenous injection). Dosing details not specified in the trial summary; product SmPC metadata lists a max daily dose amount of 1200 mg.
Target Sample Size
180

Eligibility

Recruits 180 Vulnerable population not selected (isVulnerablePopulationSelected: false). Subject information sheets and informed consent forms are provided for adults and for incapacitated subjects (documents include 'L1_SIS incapacitated subjects_Centers' and 'L1_SIS incapacitated subjects_Sponsor'), indicating procedures for obtaining consent/consent from legally authorised representatives for incapacitated participants..

Pregnancy Exclusion
Pregnancy
Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected: false). Subject information sheets and informed consent forms are provided for adults and for incapacitated subjects (documents include 'L1_SIS incapacitated subjects_Centers' and 'L1_SIS incapacitated subjects_Sponsor'), indicating procedures for obtaining consent/consent from legally authorised representatives for incapacitated participants.

Inclusion criteria

  • {"criterion_text":"- Age≥ 18 years"}
  • {"criterion_text":"- More than 3 episodes of fast-VT/VF treated by the internal or external defibrillator in the 12 hours before randomization and at least one in the three hours before."}
  • {"criterion_text":"- Fast-VT or FV requiring internal or external treatment"}
  • {"criterion_text":"- Any structural heart disease"}
  • {"criterion_text":"- Acute or choric coronary disease"}
  • {"criterion_text":"- CPVT"}

Exclusion criteria

  • {"criterion_text":"- Brugada syndrome or early repolarization syndrome"}
  • {"criterion_text":"- Known allergy or hypersensitivity or previous idiosyncrasy to amiodarone, lidocaine, bupivacaine or to other anesthetics allowed in the study"}
  • {"criterion_text":"- Other contraindications to amiodarone administration (e.g. QT prolongation, LQT syndrome, severe bradycardia, second or third degree atrio-ventricular block)"}
  • {"criterion_text":"- Neck judged unfeasible for the procedure by the clinicians"}
  • {"criterion_text":"- Previous heart transplantation"}
  • {"criterion_text":"- Previous surgical sympathetic denervation"}
  • {"criterion_text":"- Previous ablation of the stellate ganglion block"}
  • {"criterion_text":"- Ongoing treatment with intravenous AAD drugs. Enrolment may be possible under certain circumstances (see Table 3 page 62-63) in case of recurrences after discontinuation"}
  • {"criterion_text":"- Refractory cardiac arrest"}
  • {"criterion_text":"- Active enrollment in another pharmacological study"}
  • {"criterion_text":"- Pregnancy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- proportion of patients with complete suppression of treated VA (with ATP, internal DC shock or external DC shock) during the first three hours after treatment","definition_or_measurement_approach":"Proportion (number) of patients with complete suppression of treated ventricular arrhythmia (treated VA) as evidenced by absence of ATP, internal DC shock or external DC shock during the first three hours after treatment."}

Recruitment

Planned Sample Size
180
Recruitment Window Months
24
Consent Approach
Informed consent to be obtained from adult participants (Age ≥ 18). Subject information sheets and informed consent forms are provided for adults and for incapacitated subjects (documents listed: 'L1_SIS adults_Centers', 'L1_SIS adults_Sponsor', 'L1_SIS incapacitated subjects_Centers', 'L1_SIS incapacitated subjects_Sponsor', 'L1_ICF adults-for publication'). For incapacitated subjects, specific SIS/ICF documents are provided indicating consent will follow procedures for legally authorised representatives. Languages of consent documents are not specified in the available data.

Geography

Total Number Of Sites
13
Total Number Of Participants
180

Italy

Earliest CTIS Part Ii Submission Date
17-11-2025
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
8
Number Of Sites
13
Number Of Participants
180

Sites

Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
S.C. Cardiologia
Contact Person Name
Simone Savastano
Contact Person Email
s.savastano@smatteo.pv.it
Site Name
Azienda Unita Sanitaria Locale Umbria 1
Department Name
Reparto di Cardiologia-UTIC
Contact Person Name
Nicolò Sisti
Contact Person Email
nic.sisti@gmail.com
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità Operativa di Aritmologia ed Elettrofisiologia Cardiaca
Contact Person Name
Giuseppe D'Angelo
Contact Person Email
dangelo.giuseppe@hsr.it
Site Name
Azienda USL Toscana Centro
Department Name
S.O.S. Cardiologia e Elettrofisiologia SMN
Contact Person Name
Alessandro Paoletti Perini
Site Name
ARNAS G. Brotzu
Department Name
SC Cardiologia e UTIC
Contact Person Name
Matteo Casula
Contact Person Email
matt.casula@gmail.com
Site Name
Azienda Ospedaliera di Padova
Department Name
U.O.C. Cardiologia
Contact Person Name
Federico Migliore
Contact Person Email
federico.migliore@unipd.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
S.C. Cardiologia 1 Emodinamica
Contact Person Name
Claudia Colombo
Site Name
Azienda Ospedaliera Di Perugia
Department Name
S.C. Cardiologia
Contact Person Name
Francesco Notaristefano
Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
UOC Cardiologia
Contact Person Name
Valeria Carinci
Site Name
Policlinico San Donato S.p.A.
Department Name
Unità di Cardiologia Clinica, Interventistica e di Terapia Intensiva Coronarica (UTIC)
Contact Person Name
Andrea Borin
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
S.C. Cardiologia
Contact Person Name
Edoardo Gandolfi
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C. Cardiologia
Contact Person Name
Gaetano Maria De Ferrari
Site Name
Centro Cardiologico Monzino S.p.A.
Department Name
Ventricular Intensive Care (VIC) Uni
Contact Person Name
Corrado Carbucicchio

Sponsor

Primary sponsor

Full Name
Fondazione IRCCS Policlinico San Matteo
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
BUPISEN 5 mg/ml soluzione iniettabile
Active Substance
Bupivacaine hydrochloride
Modality
Small molecule
Routes Of Administration
PARAVERTEBRAL USE
Route
PARAVERTEBRAL USE
Authorisation Status
Authorised (marketing authorisation information present)
Maximum Dose
150 mg (maxTotalDoseAmount)
Investigational Product Name
Lidocaina Kabi 20 mg/ml soluzione iniettabile
Active Substance
Lidocaine hydrochloride monohydrate
Modality
Small molecule
Routes Of Administration
PARAVERTEBRAL USE
Route
PARAVERTEBRAL USE
Authorisation Status
Authorised (marketing authorisation information present)
Maximum Dose
600 mg (maxTotalDoseAmount)
Investigational Product Name
Amiodarone Hikma 50 mg/ml soluzione iniettabile
Active Substance
Amiodarone hydrochloride
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INJECTION
Route
INTRAVENOUS INJECTION
Authorisation Status
Authorised (marketing authorisation information present)
Maximum Dose
1200 mg (maxDailyDoseAmount)

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