Danon Disease Natural History Study
Start Date
12/20/2023
Completion Date
3/1/2030
Summary
The goal of this international observational study is to learn about the natural history of Danon disease in male patients (≥8 years of age) and female patients (8 to 50 years of age).
Detailed Description
This is an international observational study with both retrospective and prospective data collection. The study is designed to describe the natural history of Danon disease, a rare X-linked genetic disorder, and one of the most severe and penetrant forms of inherited cardiomyopathy. This study will collect data about the clinical course of Danon disease, including signs and symptoms, key clinical events, and the impact of the disease on quality of life as managed with the current standard of care. A hybrid (retrospective and prospective data collection) approach is being used to generate robust and longitudinal data. A subset of patients will be used as an External Control Arm for comparison to RP-A501 Trial participants.
Eligibility Criteria
Age Range: 8 years to No maximum
Interventions
No intervention
Conditions
Locations
Phoenix Children's Hospital
Phoenix, Arizona 85016
United States
University of California, San Diego
La Jolla, California 92037
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
University of Florida College of Medicine
Gainesville, Florida 32610
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Washington University
St Louis, Missouri 63110
United States
Columbia University Medical Center/New York Presbyterian
New York, New York 10032
United States
University of Texas, Southwestern
Dallas, Texas 75235
United States
Texas Children's Hospital
Houston, Texas 77030
United States
German Heart Center Munich
München,
Germany
Sheba Medical Center
Ramat Gan, 5265601
Israel
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, 50139
Italy
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid
Spain
Sant Joan de Déu Hospital
Barcelona, 08950
Spain
University College London - Great Ormond Street Institute of Child Health
London, WC1N 1DZ
United Kingdom