Do You Have LMNA-Related Dilated Cardiomyopathy (DCM)?

You may be eligible to participate in the SUNBEAM-LMNA clinical trial, a research study evaluating NVC-001, an investigational one-time gene therapy for adults living with LMNA-related DCM.

By participating in this study, patients may help researchers better understand LMNA-related DCM and advance future treatment options for the LMNA-related DCM community.

Do YouHave LMNA-Related Dilated Cardiomyopathy (DCM)?

You may be eligible to participate in the SUNBEAM-LMNA clinical trial, a research study evaluating NVC-001, an investigational one-time gene therapy for adults living with LMNA-related DCM.

By participating in this study, patients may help researchers better understand LMNA-related DCM and advance future treatment options for the LMNA-related DCM community.

What is the SUNBEAM-LMNA Study?

LMNA-related DCM is a genetic condition that affects the heart muscle and can lead to abnormal heart rhythms and heart failure. The purpose of the SUNBEAM-LMNA study is to learn more about the safety of NVC-001 and how it may affect heart function and overall health in people living with LMNA-related DCM.

Participants will receive study-related evaluations and care from experienced medical teams throughout the study. NVC-001 is administered as a one-time infusion through a vein in the arm.

Participation in this study is voluntary, and the study team will answer any questions you may have before you decide whether to participate.

To help make participation possible for patients, the study sponsor will arrange and cover the costs of travel, meals, and accommodations related to study visits.

Who Can Join the SUNBEAM-LMNA Study?

You may be eligible if you:

Are 18 years of age or older

Have a confirmed diagnosis of LMNA-related DCM

Have mild to moderate heart failure symptoms (NYHA Class I–III)

Have had an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) implanted for at least 3 months

Additional eligibility criteria will apply.
A member of the study team will review all study requirements with you.

What Can I Expect During the Study?

Participation in the SUNBEAM-LMNA study lasts approximately 2 years and includes clinic visits, heart assessments, study treatment, and follow-up evaluations.

Review & Sign the Informed Consent Form

You will meet with the study team to learn about the study, ask questions, and decide whether participation is right for you.

Screening Assessments

The study team will perform tests and evaluations to determine whether you are eligible for the study. These assessments may take place over several visits.

Pre-Treatment

If you qualify for the study, you will receive medications designed to help prepare your immune system before receiving the study treatment.

Study Treatment
and Follow-up

You will receive a one-time infusion of NVC-001 during a hospital stay that lasts a few days. After you leave the hospital, you need to stay near the hospital for a couple of weeks. Then, for 2 years after treatment, you will return to the study site for regularly scheduled follow-up visits. During these visits, the study team will monitor your health, heart function, and overall well-being.

Long Term Follow-Up

You will be invited to join a long-term follow-up study. This additional study will help researchers better understand the long-term safety and effects of NVC-001.

What Are the Possible Risks?

All clinical research studies involve possible risks. Because NVC-001 is an investigational gene therapy, not all risks may be known at this time.

Potential risks may include:

Side effects related to NVC-001 or medications used during the study
Reactions from the body's immune system
Changes in laboratory test results, including liver function tests
Risks associated with blood draws, imaging studies, heart monitoring, and other study procedures
Unexpected side effects that researchers do not yet know about

The study team will closely monitor participants throughout the study.

Before you decide whether to participate, the research team will review the known risks, study procedures, and your rights as a participant.

Interested in the SUNBEAM-LMNA study?

If you're interested and would like to learn more, please contact info@nuevocor.com.‍ A member of our team will connect you with the study team at a participating site.

Thank you for your interest in advancing research for LMNA-related DCM.