Answers to questions about MyClimb
The MyClimb Study is sponsored by Tenaya Therapeutics, Inc., a biotechnology company committed to discovering, developing and delivering curative therapies that address the underlying drivers of heart disease.
Natural history studies track the course of a condition over time, identifying demographic, genetic, environmental and other factors that correlate with progression and outcomes. A thorough understanding of the natural history of a disease is the foundation of the development of new therapies. MyClimb is a Natural History Study designed to document the course of cardiomyopathy in children and adolescents with the MYBPC3 genetic mutation. The results will inform the development and clinical trial design of potential new treatments, including gene therapies.
The MyClimb Study has been carefully designed to collect data that will provide researchers more information about MYBPC3 genetic mutation. The study insights will enhance the development of potential new therapies.
Two types of information will be collected for each subject:
- Prospective (collected during subject visits): Data will be collected during your regular visits to your study doctor’s office. This means collection of information about your heart disease from the moment you sign and date this consent and for up to 5 years.
- Retrospective (collected from your chart information): Information that has already been collected by your study doctor as part of your past doctor’s office visits will be shared. This study will look at data like your medical charts collected up to 10 years ago.
This study is not considered a Phase 1, 2 or 3 study. It is purely an observational trial that is designed to look at the course of a disease over time without any type of investigational treatment or intervention. Participation in this study will not impact your routine care.
While the study is designed to collect and assess the medical data of patients with the MYBPC3 genetic mutation, no individual names or identifying information will be shared with the study sponsor as part of the study. Your medical data will be accessible only by the researchers, including the study sponsor, Tenaya Therapeutics, and its partners, contractors and agents.
Study data will be collected as part of regularly planned physician visits and recorded by a child’s personal cardiologist or nurse.
All study data will be stored in a secured database only accessible to those directly involved in the study.
Participation in the MyClimb Study is designed to be simple for the participants. Assessments will be completed as part of a participant’s regularly planned physician visits.
A MyClimb Study participant’s physician visits will include the typical assessments that are conducted as part of a regular office visit, with additional study related activities, such as questionnaires provided by physicians to participants and blood tests conducted by the physician’s staff. You or your caretaker will be asked to complete quality of life questionnaires (surveys) throughout the study. These questions may ask about your heart health, how you are feeling emotionally and physically and how often you may be feeling a certain way. You do not have to answer questions that make you uncomfortable.
Your participation on the prospective portion will last for up to 5 years. For your participation in the retrospective portion, your study doctor will look at your medical chart data from up to 10 years ago. Participation is entirely voluntary, and you are free to leave the study any time without any impact or penalty on your routine care.
Compensation may be available for travel expenses and study-related blood draws.
The data collected as part of the MyClimb Natural History Study are intended to inform the development and clinical trial design of investigational drug products, including gene therapies. In addition to informing the development of future studies, the combined data and analysis from participating centers involved in the MyClimb Study may lead to publications that ultimately contribute to the overall collection of information available on cardiomyopathy. No personally identifying information will be disclosed in the publications.
A participant may withdraw from the study at any time at a parent’s or legal guardian’s request or may be withdrawn at any time at the discretion of the Sponsor or Investigator for various reasons, including, but not limited to, health status, safety, compliance or administrative reasons. If the participant’s parent or legal guardian withdraws consent for disclosure of future information, Researchers, including the study sponsor, Tenaya Therapeutics, and its partners, contractors and agents, may retain and continue to use any data collected before such a withdrawal of consent. If a participant is withdrawn from the study, the parent or legal guardian may request destruction of any samples taken and not tested, and the Investigator must document this in the study center study records.
Assessments for the MyClimb Study will be collected during regular physician visits. Any changes to your planned office visits will be communicated directly by your physician. Participation in this study will not impact your routine care or standard of care in any way.
The study will be conducted in about 40 sites worldwide with about 100 subjects.
There is no guarantee that you will receive any benefit from taking part in this study. Information obtained from the study may help researchers in the development of better treatments for CM. Some procedures that will be done during the study may carry some risks, listed below. Your study doctor can provide more information to you as well.
The main risk of allowing us to store and use your samples and certain limited health information for research is a potential loss of privacy. We will protect your privacy by labeling your samples and information only with a code, and keeping the key to the code in a password protected file.
There is a chance that you may be the subject of discrimination if the results of genetic testing show a genetic disorder. Researchers will not release any information to anyone without your written permission. However, it is possible that genetic information may be revealed to others through legal means and may affect your ability to obtain insurance or get a job. In cases where parents and children are both tested, tests may reveal the possibility that the father is not the biological parent.
The use of technology as part of this study can present risk. It is possible that private data from a mobile device may be accessed by others should you lose your mobile device or lend the device to other people. Some additional risks are related to a loss of confidentiality, especially when using electronic devices to share, store, and enter information. There is some possibility that other people may see your open smartphone communications. In addition, certain applications may affect the battery life of the device.
It is highly recommended that you set up a passcode on your own phone and/or electronic device to help prevent unapproved access to your device and research Study data. It’s also recommended that a remote disable feature be set up on your device in case it’s lost or stolen. This will allow you to remotely disable or remove any apps and/or data.
There may be risks that are currently unknown.
You can choose whether you want to take part in the study, and you can change your mind at any time. If you decide not to take part, or stop taking part after the study has started, this will not affect your future treatment and care and you should contact your study doctor or study staff. You may also withdraw from this research and request that your sample be destroyed at any time until your sample becomes non-identified. However, once the Sponsor removes your identification from the sample, you will not be able to withdraw from this research because the Sponsor will not know which sample is yours.
For more information about the study, including the Parental Permission and Subject Informed Consent Form and HIPAA Authorization to Use and Disclose Protected Health Information (PHI), please contact your study doctor.