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Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Sponsor: Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)
Summary
This observational, multicenter, retrospective and prospective study aims to evaluate the effect of lomitapide treatment on Major Adverse Cardiovascular Events (MACE) in patients with Homozygous Familial Hypercholesterolemia (HoFH). HoFH is a rare genetic disorder characterized by extremely high levels of LDL cholesterol (LDL-C), leading to an increased risk of early cardiovascular diseases. Lomitapide is an approved medication that lowers LDL-C levels by inhibiting microsomal triglyceride transfer protein (MTP). The study will collect data from patients who have been treated with lomitapide for at least 12 months and will compare the incidence of MACE during the first three years of treatment with the three years before treatment initiation. The study includes data collection from multiple lipid centers across Europe. The primary objective is to assess the impact of lomitapide on MACE, while secondary objectives include evaluating changes in lipid profiles, liver function tests, and lipid-lowering treatments.
Official title: Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia: A Multicenter, Retrospective and Prospective Observational Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
73
Start Date
2024-09-09
Completion Date
2026-12
Last Updated
2026-02-20
Healthy Volunteers
No
Conditions
Locations (30)
CHRU Lille - Centre Hospitalier Universitaire de Lille
Lille, France
Centre Hospitalier Universitaire de Lyon (CHU Lyon)
Lyon, France
Hôpital de la Conception - Assistance Publique Hôpitaux de Marseille (AP-HM)
Marseille, France
Hôpital La Pitié Salpêtrière - Groupe Hospitalier "La Pitié Salpêtrière - Charles Foix"
Paris, France
Strasbourg University Hospital (CHU Strasbourg)
Strasbourg, France
University General Hospital of Ioannina
Ioannina, Greece
METROPOLITAN HOSPITAL, Piraeus
Piraeus, Greece
Policlinico di Catanzaro - A.O.U. Mater Domini
Catanzaro, Calabria, Italy
Ospedale Sant'Anna e San Sebastiano
Caserta, Campania, Italy
Policlinico Federico II di Napoli
Naples, Campania, Italy
Policlinico Sant'Orsola - Università di Bologna
Bologna, Emilia-Romagna, Italy
Arcispedale Sant'Anna - Università degli Studi di Ferrara
Ferrara, Emilia-Romagna, Italy
Ospedale Civile di Baggiovara - A.O.U. di Modena
Modena, Emilia-Romagna, Italy
DIMI - Dipartimento di Medicina Interna, Università di Genova
Genova, GE, Italy
ARNAS Garibaldi
Catania, Italy, Italy
Policlinico Umberto I - Sapienza Università di Roma
Rome, Lazio, Italy
Ospedale Bassini - ASST Nord Milano
Milan, Lombardy, Italy
Policlinico Paolo Giaccone - Università degli Studi di Palermo
Palermo, Sicily, Italy
Ospedale San Luigi Gonzaga
Orbassano, Torino, Italy
A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette
Torino, Torino, Italy
CNR Gabriele Monasterio - Centro di Aferesi, Pisa
Pisa, Tuscany, Italy
Policlinico di Padova - A.O.U. di Padova
Padova, Veneto, Italy
Ospedale Borgo Trento - A.O.U. Integrata Verona
Verona, Veneto, Italy
Ospedale regionale generale "F. Miulli"
Bari, Italy
Radboud University Medical Centre
Nijmegen, Netherlands
Rotterdam Erasmus Medical Center
Rotterdam, Netherlands
Queen Elizabeth Hospital Birmingham (QEII - Birmingham)
Birmingham, England, United Kingdom
Harefield Hospital - Royal Brompton & Harefield NHS Foundation Trust
Harefield, England, United Kingdom
Hammersmith Hospital - Imperial College Healthcare NHS Trust
London, England, United Kingdom
Manchester University Hospital - NHS Foundation Trust
Manchester, England, United Kingdom