Registry for understanding cardiovascular issues in Fabry Disease
Italian Anderson Fabry Disease Cardiovascular Registry
This study is trying to learn more about heart problems in people with Fabry Disease to help improve their care and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 54 sites (Chieti, Abruzzo/Chieti and 53 other locations) |
| Trial ID | NCT06806813 on ClinicalTrials.gov |
What this trial studies
The RICMAF Study is an observational, multicenter initiative in Italy aimed at improving the understanding of Anderson-Fabry Disease (AFD), particularly its cardiac manifestations. By collecting data from a nationwide patient registry, the study seeks to analyze the clinical profile, prevalence, and incidence of AFD, as well as identify early markers of cardiac involvement and predictors of cardiovascular complications. The study also aims to explore the relationship between genetic mutations and clinical presentation to enhance personalized care for patients. This comprehensive approach is designed to improve patient outcomes through better understanding and management of the disease.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with Anderson Fabry Disease who are aged 2 years or older.
Not a fit: Patients who do not have a diagnosis of Anderson Fabry Disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of Fabry Disease, particularly in preventing cardiovascular complications.
How similar studies have performed: Other studies focusing on the clinical aspects of rare diseases like Fabry Disease have shown promise, indicating that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with Anderson Fabry disease * Age ≥ 2 years at diagnosis * Obtaining informed consent from the patient and parent or legal guardian. Exclusion Criteria: \- None
Where this trial is running
Chieti, Abruzzo/Chieti and 53 other locations
- ASL 2 Chieti - Ospedale Policlinico SS. Annunziata — Chieti, Abruzzo/Chieti, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Regionale S.Carlo — Potenza, Basilicata/Potenza, Italy (Not_yet_recruiting)
- AORN "Sant'Anna e San Sebastiano" di Caserta — Caserta, Caserta, Italy (Not_yet_recruiting)
- Azienda Ospedaliero - Universitaria "Mater Domini — Catanzaro, Catanzaro, Italy (Not_yet_recruiting)
- Azienda Ospedaliera di Cosenza Università della Calabria — Cosenza, Cosenza, Italy (Not_yet_recruiting)
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, EmiliaRomagna/Bologna, Italy (Recruiting)
- IRCCS Ospedale Policlinico San Martino — Genova, Genova, Italy (Not_yet_recruiting)
- ASST Papa Giovanni XXIII — Bergamo, Lombardia/Bergamo, Italy (Recruiting)
- U.O.Cardiologia Spetali Civili 1 — Brescia, Lombardia/Brescia, Italy (Not_yet_recruiting)
- IRCCS Ospedale Maggiore Policlinico di Milano — Milan, Lombardia/Milano, Italy (Not_yet_recruiting)
- IRCCS San Gerardo dei Tintori - S.C. Nefrologia, Monza - Università di Milano Bicocca — Milan, Lombardia/Milano, Italy (Not_yet_recruiting)
- Centro Cardiologico Monzino — Milan, Lombardia/Milano, Italy (Recruiting)
- Ospedale Niguarda — Milan, Lombardia/Milano, Italy (Not_yet_recruiting)
- IRCCS Policlinico San Donato — San Donato Milanese, Lombardia/Milano, Italy (Not_yet_recruiting)
- A O Universitaria Ospedali Riuniti Ancona — Ancona, Marche/Ancona, Italy (Recruiting)
- Clinica cardiologica AZ ospedaliera Torrette — Ancona, Marche/Ancona, Italy (Not_yet_recruiting)
- AO Dei Colli - Ospedale Monaldi — Naples, Napoli, Italy (Recruiting)
- AOU Policlinico — Naples, Napoli, Italy (Not_yet_recruiting)
- Azienda Ospedaliero-Universitaria di Parma — Parma, Parma, Italy (Not_yet_recruiting)
- Azienda Ospedaliera "Guglielmo da Saliceto" di Piacenza — Piacenza, Piacenza, Italy (Not_yet_recruiting)
- Ospedale Ivrea — Ivrea, Piemonte/Ivrea, Italy (Not_yet_recruiting)
- Ospedale Maggiore della Carità — Novara, Piemonte/Novara, Italy (Not_yet_recruiting)
- Molinette — Torino, Piemonte/Torino, Italy (Recruiting)
- Ospedale Koelliker di Torino — Torino, Piemonte/Torino, Italy (Not_yet_recruiting)
- Policlinico Bari — Bari, Puglia/Bari, Italy (Recruiting)
- A O Universitaria Ospedali Riuniti di Foggia — Foggia, Puglia/Foggia, Italy (Not_yet_recruiting)
- Ospedale Casa Sollievo della sofferenza — Manfredonia, Puglia/Foggia, Italy (Not_yet_recruiting)
- Ospedale Vito Fazzi — Lecce, Puglia/Lecce, Italy (Not_yet_recruiting)
- Ospedale SS.ma Annunziata — Taranto, Puglia/Taranto, Italy (Recruiting)
- Ospedale Metropolitano Riuniti "Bianchi - Melacrino - Morelli — Reggio Calabria, Reggio Calabria, Italy (Not_yet_recruiting)
- Arcispedale S.Maria Nuova — Reggio Emilia, Reggio Emilia, Italy (Recruiting)
- Ospedale degli Infermi di Rimini, AUSL Romagna — Rimini, Rimini, Italy (Not_yet_recruiting)
- Policlinico "Tor Vergata" — Roma, Roma, Italy (Not_yet_recruiting)
- Policlinico Gemelli — Roma, Roma, Italy (Recruiting)
- Policlinico Umberto I - Università Sapienza — Roma, Roma, Italy (Not_yet_recruiting)
- Policlinico Casilino — Roma, Roma, Italy (Not_yet_recruiting)
- Ospedale Sant'Andrea — Roma, Roma, Italy (Not_yet_recruiting)
- San Camillo Forlanini — Roma, Roma, Italy (Not_yet_recruiting)
- Ospedale S.Giovanni di Dio e Ruggì d'Aragona — Salerno, Salerno, Italy (Not_yet_recruiting)
- Azienda Ospedaliera G. Brotzu — Cagliari, Sardegna/Cagliari, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Universitaria — Cagliari, Sardegna/Cagliari, Italy (Not_yet_recruiting)
- Policlinico Rodolico — Catania, Sicilia/Catania, Italy (Recruiting)
- Policlinico G. Martino — Messina, Sicilia/Messina, Italy (Not_yet_recruiting)
- Policlinico P. Giaccone — Palermo, Sicilia/Palermo, Italy (Not_yet_recruiting)
- Ospedale San Donato — Arezzo, Toscana/Arezzo, Italy (Not_yet_recruiting)
- Azienda Ospedaliero Universitaria Careggi e Meyer — Florence, Toscana/Firenze, Italy (Recruiting)
- Fondazione Toscana Gabriele Monasterio — Pisa, Toscana/Pisa, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Siena — Siena, Toscana/Siena, Italy (Not_yet_recruiting)
- Ospedale S.Chiara — Trento, Trentino Alto Adige/Trento, Italy (Not_yet_recruiting)
- Azienda sanitaria universitaria Giuliano Isontina — Trieste, Triesta, Italy (Not_yet_recruiting)
+4 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Elena Biagini, MD, PhD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Elena Biagini, MD, PhD
- Email: elena.biagini@aosp.bo.it
- Phone: +39051214483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.