Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
300
Countries
1
Sites
5
Pericarditis
The aim of this study is to evaluate the effectiveness of beta-blocking therapy with bisoprolol in reduce the persistence of pericarditis symptoms at 2 and 4 weeks and the frequency of relapses at 12 months.
Key facts
- Sponsor
- Azienda Sanitaria Universitaria Friuli Centrale
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 18 Mar 2026 → ongoing
- Decision date (initial)
- 2025-10-27
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- SOC Cardiologia ASUFC Udine
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The aim of this study is to evaluate the effectiveness of beta-blocking therapy with bisoprolol in reduce the persistence of pericarditis symptoms at 2 and 4 weeks and the frequency of relapses at 12 months.
Secondary objectives 1
- Secondary endpoints: persistence of symptoms at 1 month. Frequency of relapses at 12 months. Additional secondary analysis: correlation between baseline C-reactive protein values and heart rate at first observation
Conditions and MedDRA coding
Pericarditis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10050488 | Arrhythmia sinus | 10007541 |
| 21.1 | LLT | 10066331 | Arterial hypotension | 10047065 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- (1) acute or recurrent pericarditis of any aetiology within 48 hours of symptom onset, (2) age > 18 years, (3) informed consent and willingness to follow study procedures).
Exclusion criteria 1
- (1) subacute presentation of pericarditis >48 hours after symptom onset, (2) age less than 18 years, (3) established pregnancy and lactation status, (4) resting HR less than 75bpm, (5) clinical contraindication to bisoprolol therapy.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The aim of this study is to evaluate the effectiveness of beta-blocking therapy with bisoprolol in reduce the persistence of pericarditis symptoms at 2 and 4 weeks and the frequency of relapses at 12 months
Secondary endpoints 1
- Secondary endpoints: persistence of symptoms at 1 month. Frequency of relapses at 12 months. Additional secondary analysis: correlation between baseline C-reactive protein values and heart rate at first observation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB13096MIG · Substance
- Active substance
- Bisoprolol
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1.25 mg milligram(s)
- Max total dose
- 1.25 mg milligram(s)
- Max treatment duration
- 28 Day(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
Azienda Sanitaria Universitaria Friuli Centrale
- Sponsor organisation
- Azienda Sanitaria Universitaria Friuli Centrale
- Address
- Piazzale Santa Maria Della Misericordia 15
- City
- Udine
- Postcode
- 33100
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Sanitaria Universitaria Friuli Centrale
- Contact name
- SOC Cardiologia
Public contact point
- Organisation
- Azienda Sanitaria Universitaria Friuli Centrale
- Contact name
- SOC Cardiologia
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 300 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Azienda Sanitaria Universitaria Giuliano Isontina
SC Cardiologia - Polo Cardiologico, Strada Di Fiume 447, 34149, Trieste
ASST Fatebenefratelli Sacco
Medicina Interna, Piazzale Principessa Clotilde 3, 20121, Milan
Azienda Sanitaria Universitaria Friuli Centrale
Soc Cardiologia, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Ospedale Maria Vittoria - Azienda Sanitaria Locale "Città di Torino"
Cardiologia (MR - MV), Via San Secondo, 29, Torino
A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Molinette
SOC Cardiologia, Corso Bramante, 88/90-Torino, Torino
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 |
|---|---|---|---|---|---|
| Italy | 2026-03-18 | 2026-03-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 30 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | BIP Protocollo v2_1 del 22SEPT-CLEAN | 2.1 |
| Protocol (for publication) | BIP Protocollo v2_1 del 22SEPT-TC | 2.1 |
| Protocol (for publication) | BIP_Protocollo v2 del 07_07_2025_con farmacovig_DEF | 1 |
| Protocol (for publication) | BIP_Protocollo_english_v 2 del 07_07_2025_with pharmacovigilance_signed | 1 |
| Protocol (for publication) | BIP_Scheda raccolta dati v 2 del 07_07_2025 | 1 |
| Protocol (for publication) | Scala intensita dolore pericarditico | 1 |
| Protocol (for publication) | Scheda_ADR_operatore_sanitario_segnalazione eventi avversi | 1 |
| Recruitment arrangements (for publication) | BIP_Modalita di reclutamento_v2 del 07_07_2025 | 2 |
| Recruitment arrangements (for publication) | BIP_Modalita di reclutamento_v2 del 07_07_2025_tc | 1 |
| Recruitment arrangements (for publication) | BIP_Modalita di reclutamento_v3 dd 16_01_2026 | 3 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure_en | 2 |
| Subject information and informed consent form (for publication) | BIP_Consenso partecipaz studio 07Jul2025_ | 1 |
| Subject information and informed consent form (for publication) | BIP_Consenso partecipaz studio_V3 dd 16_01_2026_CLEAN_ | 3 |
| Subject information and informed consent form (for publication) | BIP_Consenso partecipaz studio_V3 dd 16_01_2026_TC_ | 3 |
| Subject information and informed consent form (for publication) | BIP_ICF 22SEP2025_CLEAN_ | 3 |
| Subject information and informed consent form (for publication) | BIP_ICF_22SEP2025_TC_ | 3 |
| Subject information and informed consent form (for publication) | BIP_Lettera MMG v2 del 07_07_2025 | 2 |
| Subject information and informed consent form (for publication) | BIP_Lettera MMG v2 del 07_07_2025_TC | 1 |
| Subject information and informed consent form (for publication) | BIP_Lettera MMG v3 del 16_01_2026_ TC | 3 |
| Subject information and informed consent form (for publication) | BIP_Lettera MMG v3 del 16_01_2026_CLEAN | 3 |
| Subject information and informed consent form (for publication) | BIP_Privacy_v 2 del 07Jul2025 | 1 |
| Subject information and informed consent form (for publication) | BIP_Privacy_v2_0 dd22SEPT2025_CLEAN | 3 |
| Subject information and informed consent form (for publication) | BIP_Privacy_v2_0 dd22SEPT2025_TC | 3 |
| Subject information and informed consent form (for publication) | BIP_Privacy_v3 dd 16_01_2026_CLEAN | 3 |
| Subject information and informed consent form (for publication) | BIP_Privacy_v3 dd 16_01_2026_TC | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP_001896_042442 | 1 |
| Synopsis of the protocol (for publication) | BIP Sinossi v2_1 del 22SEPT25-CLEAN | 2 |
| Synopsis of the protocol (for publication) | BIP Sinossi v2_1 del 22SEPT25-TC | 2 |
| Synopsis of the protocol (for publication) | BIP_Sinossi v 2 del 07_07_2025_DEF | 1 |
| Synopsis of the protocol (for publication) | BIP_Synopsis_english_v 2 del 07_07_2025_DEF | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-11 | Italy | Acceptable 2025-10-27
|
2025-10-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-05 | Italy | Acceptable | 2026-02-17 |