Clinical trial • Not applicable • Cardiology
IBUPROFEN for Acute myocarditis
Not applicable trial of IBUPROFEN for Acute myocarditis. Paracetamol (conventional treatment) — dose and schedule not specified.-controlled.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Acute myocarditis
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 06-06-2024
- First CTIS Authorization Date
- 16-09-2024
Trial design
Paracetamol (conventional treatment) — dose and schedule not specified.-controlled Not applicable trial across 7 sites in Spain.
- Comparator
- Paracetamol (conventional treatment) — dose and schedule not specified.
- Target Sample Size
- 150
- Trial Duration For Participant
- 180
Eligibility
Recruits 150 No vulnerable population selected. Participants must be able to provide informed consent (see inclusion criterion: "Ability to provide informed consent.")..
- Pregnancy Exclusion
- Pregnancy, breastfeeding, or women of childbearing age unwilling to use appropriate contraception throughout the duration of the treatment of the study
- Vulnerable Population
- No vulnerable population selected. Participants must be able to provide informed consent (see inclusion criterion: "Ability to provide informed consent.").
Inclusion criteria
- {"criterion_text":"- Aged 18 years or older."}
- {"criterion_text":"- Patients hospitalized for confirmed acute myocarditis and left ventricular ejection fraction ventricular ≥50%."}
- {"criterion_text":"- Absence of acute heart failure."}
- {"criterion_text":"- Exclusion of ischemic heart disease."}
- {"criterion_text":"- Diagnostic criteria for myocarditis by cardiac magnetic resonance imaging."}
- {"criterion_text":"- Ability to provide informed consent."}
Exclusion criteria
- {"criterion_text":"- Kidney disease stage 3b, 4 and 5 or severe liver failure."}
- {"criterion_text":"- Uncontrolled hypertension."}
- {"criterion_text":"- Diagnosis criteria for acute pericarditis."}
- {"criterion_text":"- Moderate or severe pericardial effusion."}
- {"criterion_text":"- Hypersensitivity to Non-steroidal anti-inflammatory drugs or previous use in the last seven days."}
- {"criterion_text":"- Contraindication for cardiac magnetic resonance."}
- {"criterion_text":"- Pregnancy, breastfeeding, or women of childbearing age unwilling to use appropriate contraception throughout the duration of the treatment of the study"}
- {"criterion_text":"- Known autoimmune disease that, in the investigator's opinion, could be the cause of myocarditis and requires immunosuppressive treatment."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change in late gadolinium enhancement (measured in % relative to indexed myocardial mass) compared to baseline (cardiac magnetic resonance at admission) in each treatment group at 6 months after diagnosis.","definition_or_measurement_approach":"Measured as percentage relative to indexed myocardial mass on cardiac magnetic resonance (baseline at admission) and compared at 6 months after diagnosis."}
Recruitment
- Planned Sample Size
- 150
- Recruitment Window Months
- 28
- Consent Approach
- Participants must be able to provide informed consent (inclusion criterion). Subject information and informed consent form document is present (L1_SIS and ICF participants). No paediatric/assent procedures specified. Documentation and translations in Spanish are present in the application materials.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 150
Spain
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 477
- Number Of Sites
- 7
- Number Of Participants
- 150
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Cardiology
- Contact Person Name
- María Vidal Burdeus
- Contact Person Email
- m_vidal88@hotmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Cardiology
- Contact Person Name
- Mireia Padilla López
- Contact Person Email
- padilla.mireia@gmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Cardiology
- Contact Person Name
- Esther Cambronero Cortinas
- Contact Person Email
- estinas82@gmail.com
- Site Name
- Hospital Universitario De Burgos
- Department Name
- Cardiology
- Contact Person Name
- Isabel Santos Sánchez
- Contact Person Email
- aiss.isabelsantos@gmail.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Cardiology
- Contact Person Name
- María Gallego Delgado
- Contact Person Email
- m.gallego.delgado@gmail.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Cardiology
- Contact Person Name
- Fernando Domínguez Rodríguez
- Contact Person Email
- fdominguezrodriguez@gmail.com
- Site Name
- Hospital Universitario Severo Ochoa
- Department Name
- Cardiology
- Contact Person Name
- Alberto Esteban Fernandez
- Contact Person Email
- athalbertus@gmail.com
Sponsor
Primary sponsor
- Full Name
- Centro Nacional De Investigaciones Cardiovasculares Carlos III
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Third parties
- {"country":"Spain","full_name":"Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda","duties_or_roles":"","organisation_type":"Patient organisation/association"}
Co-sponsors
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
Investigational products
- Investigational Product Name
- IBUPROFEN
- Active Substance
- IBUPROFEN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (SmPC provided)
- Maximum Dose
- 1800 mg per day
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