NCT06224660 Modulation of SERCA2a of Intra-Myocytic Calcium Trafficking in Cardiomyopathy Secondary to Duchenne Muscular Dystrophy
| NCT ID | NCT06224660 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sardocor Corp. |
| Condition | DMD-Associated Dilated Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-10-02 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-10-02 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This research study is testing whether an experimental drug, called SRD-001, is safe and helps the weakened heart of patients with Duchenne muscular dystrophy (DMD) regain its ability to effectively pump blood to the rest of the body. SRD-001 is a form of gene therapy. The goal of SRD-001 gene therapy is to provide the heart muscle cells with extra copies of the SERCA2a gene so that they can produce more SERCA2a protein to help the heart muscle cells squeeze/contract better. Researchers will compare SRD-001 treated participants with no-treatment participants; all participants will continue to take their current heart medications. All participants will be followed very closely for 2 years and undergo cardiac magnetic resonance imaging of their heart at baseline, year 1 and year 2 along with assessment of upper limb function and lung function. After the 2 years of close follow-up, all participants will roll over into long-term follow-up where they will be called biannually for information on their current medical status.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of DMD with confirmatory genetic testing * Cardiomyopathy with left ventricular scar in at least 3 of 16 segments * Left ventricular ejection fraction \< 40% * Individualized, optimized cardiac medical therapy and glucocorticoid treatment for at least 12 months prior to enrollment * Willing and able to provide informed consent Exclusion Criteria: * Abnormal blood pressure * Non-DMD-related liver function test elevations * Cystatin C ≥ 1.2 mg/L * Thrombocytopenia * Anemia * Inadequate pulmonary function
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06224660 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying DMD-Associated Dilated Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06224660 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06224660 currently recruiting?
Yes, NCT06224660 is actively recruiting participants. Contact the research team at info@sardocorcorp.com for enrollment information.
Where is the NCT06224660 trial being conducted?
This trial is being conducted at Kansas City, United States, Cincinnati, United States, Columbus, United States.
Who is sponsoring the NCT06224660 clinical trial?
NCT06224660 is sponsored by Sardocor Corp.. The trial plans to enroll 12 participants.