RIDGE:
An Antibody Testing and Observational Study
RIDGETM is an antibody testing and observational study designed to learn about the levels of AAV antibodies in people with ARVC caused by a PKP2 mutation. It is also designed to provide valuable information about who might be eligible for and benefit from an AAV-based gene therapy such as TN-401.
Who can take part in the RIDGE study?
People between the ages of 14 – 65 who have the PKP2 gene mutation with a diagnosis of ARVC.
Study staff will evaluate people interested in taking part in RIDGE and determine if they are eligible. These are not all of the eligibility criteria for this study.
What is the purpose of the RIDGE study?
This study has been carefully designed to collect data such as people’s medical information, family history, and other related information that will provide researchers with more information about the condition and the PKP2 genetic mutation. The RIDGE study is an antibody testing and observational study that will enroll approximately 200 participants at about 30 sites worldwide.
What to expect in the RIDGE study?
During the five-year study, researchers will gather data to help evaluate the disease course, burden of illness, risk factors, and biomarkers (measurable characteristics of ARVC such as protein levels in the blood) associated with disease progression.
Two types of information will be gathered for each participant:
Prospective
(collected during participant visits)
Data will be collected during the participant’s usual visits to the study doctor’s office from time of enrollment for up to 5 years.
Retrospective
(collected from medical chart information)
Information that has already been collected as part of past doctor’s visits. This study will look at data in medical charts collected up to 10 years ago.
For the prospective part of the study, data will be collected as part of regularly planned doctor visits and recorded by a cardiologist or nurse.
These visits will include the typical tests that are conducted as part of a regular office visit, with additional study-related activities, such as:
Filling out quality-of-life questionnaires (surveys) throughout the study
The surveys may include questions about heart health, emotional and physical wellbeing, and how often a person may feel a certain way.
Blood tests to learn about the levels of AAV antibodies in people with ARVC with a PKP2 mutation
The study will not require any extra visits with a participant’s doctor. Participation is entirely voluntary, and participants are free to leave the study at any time without impact to routine care.
Participation in the RIDGE study is entirely voluntary. There is no cost to participate in this study.
Study locations
The RIDGE study is being conducted in leading cardiovascular research centers in North America and Europe.
United States Locations
California Locations
San Francisco, California, United States, 94143
Recruiting
University of California San Francisco
Contact: Vasanth Vedantham, MD, PhD
Colorado Locations
Aurora, Colorado, United States, 80045
Recruiting
University of Colorado, Denver
Contact: Matthew Taylor, MD, PhD
Maryland Locations
Baltimore, Maryland, United States, 21287
Recruiting
John Hopkins University School of Medicine
Contact: Hugh G Calkins, MD
Massachusetts Locations
Boston, Massachusetts, United States, 02115
Recruiting
Brigham and Women's Hospital
Contact: Neal Lakdawala, MD
Minnesota Locations
New York Locations
Ohio Locations
South Carolina Locations
Charleston, South Carolina, United States, 29425
Recruiting
Medical University of South Carolina
Contact: Daniel Judge, MD
France Locations
Germany Locations
Italy Locations
Sweden Locations
United Kingdom Locations
London, United Kingdom, E1 1BB
Recruiting
Barts & The London Health NHS Trust
Contact: Perry Elliott, MD
London, United Kingdom, SW17 0QT
Recruiting
St. George's University Hospitals NHS Foundation Trust
Contact: Elijah Behr, MD
London, United Kingdom, SW3 6NP
Recruiting
Royal Brompton & Harefield NHS Foundation Trust
Contact: Antonio Pantazis, MD
Scroll to see more locations
If you are interested in participating:
Talk to your doctor about whether you may be a candidate for this study
- Visit ClinicalTrials.gov (NCT06311708) to learn more
Complete this form or contact clinical.trials@tenayathera.com or patient.advocacy@tenayathera.com to request more information
