Genetic Cardiomyopathy Registry (GCR) FAQs

The Genetic Cardiomyopathy Registry (GCR) is a secure online research database that collects information from individuals with or suspected of having genetic cardiomyopathy. This valuable data helps researchers better understand these conditions, leading to improved diagnosis, treatment, and prevention methods. The GCR is an online platform collecting data from individuals with genetic cardiomyopathies to advance research and improve patient care.

The purpose of the Genetic Cardiomyopathy Registry is to bring the Cardiomyopathy community together and collect data.

Some of the goals of the Genetic Cardiomyopathy Registry are:

• To describe the people who have Cardiomyopathy and to better understand the stages of the disease and the different ways the disease affects people. To do this, we will ask about diagnosis, treatment, medical history, social and economic environment, and treatment outcomes. 
• To identify significant numbers of participants with genetic subtypes of cardiomyopathies. 
• To guide participants on where and how to obtain genetic testing. 
• To notify participants of research studies and clinical trials.
• To make genetic testing, diagnosis and research of genetic cardiomyopathies more patient-centric, while increasing health equity on a geographic, socio-economic, and diversity basis through the broad reach of the DCM Foundation and Genetic Cardiomyopathy Awareness Consortium.
• To identify people with Cardiomyopathy who might be willing to take part in other research studies or clinical trials. You will be able to choose whether you want to hear about these other studies. 

This study is open to anyone who has a Cardiomyopathy diagnosis and/or meets the study inclusion criteria for participation.

Family members of individuals with genetic cardiomyopathy are encouraged to join the registry, even if they haven’t been diagnosed themselves. This can help researchers understand how genetic cardiomyopathy is passed down through families.

Joining is simple. You can visit the registry website and provide your informed consent to enroll online.

The risks associated with joining the registry are minimal. The primary concern is the potential for data breaches, although this is mitigated through the implementation of robust security measures.

No, joining the registry will not affect your medical care in any way. Your participation is entirely voluntary and you have the freedom to withdraw from the registry at any time.

Participants are able to withdraw from the study at any time. However, researchers may still use the information that they have collected prior to the participant changing their mind. Information that has already been shared with researchers prior to withdrawal cannot be retrieved or removed.

The registry collects a range of information, including your medical and family history, genetic test results, symptoms and disease progression, treatments and their effectiveness, lifestyle factors, and your overall quality of life.

Data is collected through a secure web-based application (that can be accessed by computer, tablet or phone) developed by the National Organization for Rare Disorders, Inc. (NORD®), (learn more about NORD below). Study participants respond to questions grouped within a series of surveys developed per study standards and in collaboration with disease specific experts. 

The registry uses an online platform which allows participants to contribute data from anywhere in the world. Individuals from other countries who enter data into the registry should be aware that data and privacy laws are different in the U.S. from other countries. This U.S. based registry will protect data and privacy according to U.S. requirements.

The registry follows strict government guidelines to assure patient information is protected. The platform is served over HTTPS, which means that the data is encrypted when being sent from the user’s browser to the NORD servers. The data is also kept encrypted in the NORD database. Communications between the registry platform application server and the database are also encrypted. As with any information you provide electronically, there is a very rare chance that your privacy could be compromised. However, the registry and the security measures minimize the chance of this occurring.

NORD stores Sponsor and Participant Registry Data on NORD encrypted servers and/or encrypted servers of third-party vendors hosted in Canada. Regular back-up at commercially acceptable intervals is provided. These servers meet industry standards and are compliant with US and international regulations, including GDPR. 

The study data are owned by the study sponsor, DCM Foundation. The DCM Foundation decides how and with whom to share the data. NORD staff will have access to the data for activities related to support and maintenance of the Platform and will collect Platform-wide participation statistics. The specifics will be outlined in your informed consent. 

All data, including those with PHI, will be stored in a password protected secure server. Access to PHI will be limited to: 

• Approved members of the Genetic Cardiomyopathy Registry research team
• NORD staff, in cases where technical support is needed and with the permission of registry staff
• With agreement from the Sponsor, NORD may conduct IRB-approved, cross-disease research using registry data. 

In all cases, your privacy will be protected. The Registry Advisory Board will evaluate all requests for data from researchers. Researchers will only be provided with the minimum data necessary to accomplish their research study goals. Data containing PHI will only be shared if the research cannot be done without it. The researchers will be required to sign a Confidentiality Agreement in which they promise to keep your information safe. 

Your data will be kept in the registry indefinitely or until you choose to withdraw your consent and request the removal of your information.

For individuals living outside the United States who choose to share information about themselves, the same protections for privacy and confidentiality are offered as in the United States. Residents of the European Union and Switzerland have additional particular rights related to personal information. This information is disclosed within the informed consent document. If an individual signs this document, they acknowledge that they are disclosing information that would otherwise be private. Privacy laws in an individual’s country may have different protections than those provided in the United States.   

Registry participants who are residents of the European Union and Switzerland are entitled to:  

• Request to obtain access to and rectification or erasure of personal data;  
• Receive personal data in a portable, readily-accessible format;   
• Restrict or withdraw permission for the processing of personal information; and 
• Lodge a complaint with an appropriate supervisory authority.  

There is no cost to the patient to join this study.

You will not be paid for the information you provide.

A registry on the IAMRARE platform will typically be open for at least five years. Participants will be asked to return to the registry periodically to update their information. 

The registry is maintained by NORD who hosts the registry on its web-based application. NORD provides ongoing technical support of the system. DCM Foundation provides the day-to-day management of their patient registry. 

Yes, you have the option to opt-in to receive updates on the latest research findings and be notified about relevant studies that you may be eligible to participate in.

You will have an opportunity to opt-in to various kinds of communications from the sponsors of the registry. You will also receive an email reminder to update your survey information on an annual basis.

Formed in 2017 by a DCM Patient and a noted Heart Failure Cardiologist and DCM Genetic Researcher, the DCM Foundation’s mission is to provide HOPE and support to DCM Patients and Families with Dilated Cardiomyopathy through education, research and advocacy.

Our mission is being executed through three foundational pillars:

1. Information and Education
2. Patient and Family Support
3. Understanding the Need for Genetic Testing

In 2023, to support pillar 3, the DCM Foundation launched the Genetic Cardiomyopathy Awareness Consortium with seven other cardiomyopathy patient groups to spread awareness of the role genetics plays in cardiomyopathy.

NORD, an independent nonprofit, is leading the fight to improve the lives of rare disease patients and families by supporting the rare community, its people, and organizations. NORD works together to accelerate research, raise awareness, provide valuable information, and drive public policy that benefits the estimated 25-30 million Americans impacted by rare diseases.

Learn more about NORD at https://rarediseases.org/.