MyClimb is a natural history study designed to collect and evaluate information on the course of cardiomyopathy in infants, children and teens with the MYBPC3 genetic mutation.
Natural history studies track the course of a condition over time, identifying demographic, genetic, environmental, and other factors that may impact progression and outcomes. No investigational treatments are administered as part of a natural history study.
The data from a natural history study will inform the development and clinical trial design of potential new treatments, including gene therapies.
Who can take part in the MyClimb study?
People 18 years and younger who have the MYBPC3 gene mutation and symptoms of HCM may be eligible for the MyClimb study.
Study staff will evaluate people interested in taking part in MyClimb and determine if they are eligible. These are not all of the eligibility criteria for this study.
What is the purpose of the MyClimb 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 MYBPC3 genetic mutation. The MyClimb study will enroll approximately 300 participants at about 40 sites worldwide.
Participation in the MyClimb study is entirely voluntary. There is no cost to participate in this study.
What to expect in the MyClimb 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 HCM 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 conducted by the doctor’s office staff
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.
Will there be identifying information included in the collection of data? Who will be able to see the information gathered?
While the study is designed to collect and assess the medical data of people with the MYBPC3 genetic mutation, no individual names or identifying information will be shared with the study sponsor as part of the study. The medical data of participants will be accessible only by the researchers, including the study sponsor, Tenaya Therapeutics, and its partners, contractors and agents.
What if I would like to withdraw from the study?
Participants can choose whether they want to take part in the study, and participants can change their mind at any time.
Study locations
The MyClimb study is being conducted in leading cardiovascular research centers in North America and Europe.
United States Locations
Arkansas Locations
Little Rock, Arkansas, United States, 72202
Recruiting
Arkansas Children's Hospital
California Locations
Los Angeles, California, United States, 90027
Recruiting
Children's Hospital Los Angeles
Sacramento, California, United States, 95817
Recruiting
University of California Davis Health
San Diego, California, United States, 92123
Recruiting
Rady Children's Hospital - San Diego
Colorado Locations
Aurora, Colorado, United States, 80045
Recruiting
University of Colorado Hospital - Anschutz Medical Campus
Delaware Locations
Wilmington, Delaware, United States, 19803
Recruiting
Nemours Alfred I. Dupont Hospital for Children
Florida Locations
Hollywood, Florida, United States, 33021
Recruiting
Joe DiMaggio Children's Hospital
Missouri Locations
Kansas City, Missouri, United States, 64108
Recruiting
Children's Mercy Hospital Kansas
Saint Louis, Missouri, United States, 63110
Recruiting
St. Louis Children's Hospital
New York Locations
Bronx, New York, United States, 10467
Recruiting
Montefiore Medical Center, Albert Einstein College of Medicine
Lake Success, New York, United States, 11042
Recruiting
Cohen Children's Medical Center
New York, New York, United States, 10029
Recruiting
Mount Sinai
New York, New York, United States, 10032
Recruiting
Columbia University Irving Medical Center
Ohio Locations
Cincinnati, Ohio, United States, 45229
Recruiting
Cincinnati Children's Hospital Medical Center
Cleveland, Ohio, United States, 44195
Recruiting
Cleveland Clinic Main Campus
Middlefield, Ohio, United States, 44062
Recruiting
DDC Clinic Center for Special Needs Children
Pennsylvania Locations
Lancaster, Pennsylvania, United States, 17601
Recruiting
Cardiology Care for Children
Philadelphia, Pennsylvania, United States, 19104
Recruiting
Children's Hospital of Philadelphia
Pittsburgh, Pennsylvania, United States, 15224
Recruiting
University of Pittsburgh Medical Center - Children's Hospital of Pittsburgh
Texas Locations
Dallas, Texas, United States, 75207
Recruiting
Children's Medical Center Dallas
Houston, Texas, United States, 77030
Recruiting
Texas Children's Hospital
Canada Locations
Alberta Locations
Edmonton, Alberta, Canada, T6G 2B7
Recruiting
University of Alberta Hospital
Ontario Locations
Toronto, Ontario, Canada,
Recruiting
The Hospital for Sick Children
Spain Locations
Barcelona, Spain, 8950
Recruiting
Hospital Sant Joan de Déu Barcelona
Madrid, Spain, 28003
Recruiting
Hospital General Universitario Gregorio Marañón
Vigo, Spain, 36312
Recruiting
Hospital Alvaro Cunqueiro - Clinico Universitario Vigo
United Kingdom Locations
Glasgow, United Kingdom, G12 0XH
Recruiting
NHS Greater Glasgow and Clyde
London, United Kingdom, SW3 6NP
Recruiting
Royal Brompton & Harefield NHS Foundation Trust
London, United Kingdom, WC1N 3JH
Recruiting
Great Ormond Street Hospital for Children NHS Foundation Trust
Scroll to see more locations
Participation information
For more information about the MyClimb study, please complete this form or contact clinical.trials@tenayathera.com or patient.advocacy@tenayathera.com.
For more information about the MyClimb study visit ClinicalTrials.gov and enter NCT05112237.
