Clinical trial • Phase III • Cardiology

BISOPROLOL for Pericarditis

Phase III trial of BISOPROLOL for Pericarditis. Randomised. 300 participants.

Overview

Randomised Phase III trial across 4 sites in Italy.

Recruits 300 Vulnerable populations not selected; participants must be >18 and provide informed consent; no assent procedures described..

Pregnancy Exclusion: (3) established pregnancy and lactation status
Vulnerable Population: Vulnerable populations not selected; participants must be >18 and provide informed consent; no assent procedures described.

{"criterion_text":"- (1) acute or recurrent pericarditis of any aetiology within 48 hours of symptom onset"}
{"criterion_text":"- (2) age > 18 years"}
{"criterion_text":"- (3) informed consent and willingness to follow study procedures)."}

{"criterion_text":"- (1) subacute presentation of pericarditis >48 hours after symptom onset"}
{"criterion_text":"- (2) age less than 18 years"}
{"criterion_text":"- (3) established pregnancy and lactation status"}
{"criterion_text":"- (4) resting HR less than 75bpm"}
{"criterion_text":"- (5) clinical contraindication to bisoprolol therapy."}

{"endpoint_text":"- 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","definition_or_measurement_approach":"Measured as persistence of pericarditis symptoms at 2 and 4 weeks; frequency of relapses assessed over 12 months."}

{"endpoint_text":"- 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","definition_or_measurement_approach":"Persistence of symptoms assessed at 1 month; frequency of relapses assessed over 12 months; additional analysis correlates baseline C-reactive protein values with heart rate at first observation."}

Planned Sample Size: 300
Recruitment Window Months: 15
Consent Approach: Informed consent required from participants (inclusion: age > 18 and informed consent). Subject information and consent forms available (multiple files present, including Italian and English versions as indicated by document filenames). No assent procedures described (adults only).

Recruitment arrangements document (BIP_Modalita di reclutamento) - Italy (document titles indicate formal recruitment procedures)
Letter to General Practitioners (BIP_Lettera MMG) - Italy (GP engagement / referral via primary care)
Informed consent and patient recruitment procedure (informedconsent_patientrecruitmentprocedure_en) - English-language consent/recruitment procedure document

Site Name: Azienda Sanitaria Universitaria Friuli Centrale
Department Name: Soc Cardiologia
Principal Investigator Name: Massimo Imazio
Principal Investigator Email: studiclinici.cardiologiaudine@asufc.sanita.fvg.it
Contact Person Name: Massimo Imazio
Contact Person Email: studiclinici.cardiologiaudine@asufc.sanita.fvg.it

Site Name: Ospedale Maria Vittoria - Azienda Sanitaria Locale "Città di Torino"
Department Name: Cardiologia (MR - MV)
Principal Investigator Name: Massimo Giammaria
Principal Investigator Email: cardiologia.martini@aslcittaditorino.it
Contact Person Name: Massimo Giammaria
Contact Person Email: cardiologia.martini@aslcittaditorino.it

Site Name: A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Molinette
Department Name: SOC Cardiologia
Principal Investigator Name: Alessandro Andreis
Principal Investigator Email: alessandro.andreis@unito.it
Contact Person Name: Alessandro Andreis
Contact Person Email: alessandro.andreis@unito.it

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