Danon Disease Clinical Trials

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An Observational Study of Genetic Cardiomyopathy, Danon Disease

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Other
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Healthy Volunteers: f
View:

‣ Prospective Cohort:

• Documentation of a pathogenic or likely pathogenic variant of the LAMP2 gene by a CLIA-certified genetic testing laboratory

• Patient or parent/legal guardian are capable and willing to provide signed informed consent

• Age ≥ 8 years at enrollment

• Female Prospective Cohort:

• Evidence of left ventricular hypertrophy in the 12 months prior to or at enrollment.

• Retrospective (only) Cohort:

• Documentation of a pathogenic or likely pathogenic variant of the LAMP2 gene by a CLIA-certified genetic testing laboratory

• Patient or parent/legal guardian are capable and willing to provide signed informed consent, as required by local regulations

• Age ≥ 8 years at enrollment

• Prior cardiac transplantation or prior mechanical circulatory support

• At least 30 days of retrospective medical records available prior to cardiac transplantation or mechanical circulatory support

• Female Retrospective (only) Cohort:

⁃ Prior evidence of left ventricular hypertrophy.

Locations
United States
Arizona
Phoenix Children's Hospital
RECRUITING
Phoenix
California
University of California, San Diego
RECRUITING
La Jolla
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Florida
University of Florida College of Medicine
RECRUITING
Gainesville
Michigan
University of Michigan
RECRUITING
Ann Arbor
Missouri
Washington University
RECRUITING
St Louis
New York
Columbia University Medical Center/New York Presbyterian
RECRUITING
New York
Texas
Texas Children's Hospital
RECRUITING
Houston
Other Locations
Germany
German Heart Center Munich
RECRUITING
München
Israel
Sheba Medical Center
RECRUITING
Ramat Gan
Italy
Azienda Ospedaliera Universitaria Meyer IRCCS
RECRUITING
Florence
Spain
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
United Kingdom
University College London - Great Ormond Street Institute of Child Health
RECRUITING
London
Contact Information
Primary
Clinical Information
clinicaltrials@rocketpharma.com
646-627-0033
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2030-03
Participants
Target number of participants: 60
Treatments
Prospective Cohort
Retrospective Cohort
Related Therapeutic Areas
Sponsors
Leads: Rocket Pharmaceuticals Inc.

This content was sourced from clinicaltrials.gov

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