Study of the Quality of Life of Patients With Fabry Disease Aged 65 and Over With and Without Specific Treatment

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Fabry disease is a rare genetic disorder affecting 1 in 10,000 individuals, leading to complications such as chronic pain, heart and kidney failure, and strokes, ultimately impacting life expectancy. People with this disease are increasingly being diagnosed later in life, around the age of 65, as the condition progresses slowly with irreversible organ damage. The effectiveness of treatments for Fabry disease remains controversial, but early initiation is recommended for long-term benefits. Despite the high cost and inconvenience of treatments, there is limited research on their efficacy in older people or on the quality of life for those aged 65 and over with Fabry disease. This study aims to assess the quality of life in this age group both with and without treatment over a period of 5 years to determine the benefits of treatment beyond the age of 65.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Men and women aged 65 and over with a diagnosis of Fabry disease with, for men, a proven alpha-galactosidase A deficiency or an identified pathogenic GLA genetic variant, and for women, an identified pathogenic GLA variant.

• Minimum work-up available: ECG, 24h holterECG, cardiac ultrasound, creatinemia, proteinuria and/or microalbuminuria.

• Have received written and oral information about the protocol and have not expressed any opposition to participating in the study.

• Affiliated to a social security scheme or entitled to benefits (excluding AME).

Locations
Other Locations
France
Groupe Hospitalier Diaconesses Croix Saint-Simon
RECRUITING
Paris
Contact Information
Primary
Djazia Bouzelmat, Clinical Research Assistant
dbouzelmat@hopital-dcss.org
01 44 64 30 98
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2031-10-14
Participants
Target number of participants: 100
Treatments
Participants aged 65 or over with Fabry disease
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Tours, University Hospital, Montpellier, University Hospital, Marseille, University Hospital, Strasbourg, Hospices Civils de Lyon, Hospital, Vannes, Rennes University Hospital, Nantes University Hospital, Centre Hospitalier Universitaire Dijon, University Hospital, Clermont-Ferrand, University Hospital, Lille, University Hospital, Brest, University Hospital, Limoges, Centre Hospitalier Universitaire de Caen, Centre Hospitalier de la côte Basque, University Hospital, Angers, Necker Hospital, 75015 Paris, University Hospital, Bordeaux, University Hospital, Grenoble, Centre Hospitalier Universitaire de Nice, University Hospital, Rouen, Centre Hospitalier Bretagne Atlantique, Hôpital Raymond Poincaré
Leads: Wladimir MAUHIN, Dr

This content was sourced from clinicaltrials.gov