Overview
Sponsor-declared trial summary
Acute myocarditis
The main objective is to assess the utility of ibuprofen therapy for 3 weeks versus conventional treatment with analgesics (paracetamol) in acute myocarditis with preserved left ventricular ejection fraction, in terms of reducing late gadolinium enhancement on cardiac magnetic resonance at 6-month follow-up.
Key facts
- Sponsor
- Centro Nacional De Investigaciones Cardiovasculares Carlos III, Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 30 Jan 2025 → ongoing
- Decision date (initial)
- 2024-09-16
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
The main objective is to assess the utility of ibuprofen therapy for 3 weeks versus conventional treatment with analgesics (paracetamol) in acute myocarditis with preserved left ventricular ejection fraction, in terms of reducing late gadolinium enhancement on cardiac magnetic resonance at 6-month follow-up.
Conditions and MedDRA coding
Acute myocarditis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Aged 18 years or older.
- Patients hospitalized for confirmed acute myocarditis and left ventricular ejection fraction ventricular ≥50%.
- Absence of acute heart failure.
- Exclusion of ischemic heart disease.
- Diagnostic criteria for myocarditis by cardiac magnetic resonance imaging.
- Ability to provide informed consent.
Exclusion criteria 8
- Kidney disease stage 3b, 4 and 5 or severe liver failure.
- Uncontrolled hypertension.
- Diagnosis criteria for acute pericarditis.
- Moderate or severe pericardial effusion.
- Hypersensitivity to Non-steroidal anti-inflammatory drugs or previous use in the last seven days.
- Contraindication for cardiac magnetic resonance.
- Pregnancy, breastfeeding, or women of childbearing age unwilling to use appropriate contraception throughout the duration of the treatment of the study
- Known autoimmune disease that, in the investigator's opinion, could be the cause of myocarditis and requires immunosuppressive treatment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB08098MIG · Substance
- Active substance
- Ibuprofen
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 25200 mg milligram(s)
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centro Nacional De Investigaciones Cardiovasculares Carlos III
- Sponsor organisation
- Centro Nacional De Investigaciones Cardiovasculares Carlos III
- Address
- Calle De Melchor Fernandez Almagro 3
- City
- Madrid
- Postcode
- 28029
- Country
- Spain
Scientific contact point
- Organisation
- Centro Nacional De Investigaciones Cardiovasculares Carlos III
- Contact name
- Antonio Quesada
Public contact point
- Organisation
- Centro Nacional De Investigaciones Cardiovasculares Carlos III
- Contact name
- Antonio Quesada
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
- Sponsor organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
- Address
- Calle De Joaquin Rodrigo 2
- City
- Majadahonda
- Postcode
- 28222
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
- Contact name
- Fernando Domínguez Rodríguez
Public contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
- Contact name
- Fernando Domínguez Rodríguez
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 150 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-01-30 | 2025-04-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513803-15-00 v3 | 3 |
| Protocol (for publication) | D1_Protocol 2024-513803-15-00 | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF participants | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC ibuprofeno | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES 2024-513803-15-00 | 2 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-06 | Spain | Acceptable 2024-09-10
|
2024-09-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-20 | Spain | Acceptable 2025-03-21
|
2025-03-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-20 | Spain | Acceptable | 2025-12-02 |