Modulation of SERCA2a of Intra-Myocytic Calcium Trafficking in Cardiomyopathy Secondary to Duchenne Muscular Dystrophy
Sardocor Corp. · NCT06224660
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · Men only
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 1
- Target enrollment
- 12
- US sites recruiting
- 3
- Study start
- October 2, 2024
- Record last updated
- February 27, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: SRD-001
Conditions: DMD-Associated Dilated Cardiomyopathy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
The University of Kansas Medical Center
Kansas City, KS 66160
Site contact: Jillian Bruenn · 913-588-9720 · jfrick2@kumc.edu
Cincinnati Children's Hospital Medical Center
Cincinnati, OH 45229
Site contact: Heart Institute Neuromuscular Intake Line · 513-803-3000
Nationwide Children's Hospital
Columbus, OH 43215
Site contact: Kelsey Craig · 614-722-2715 · kelsey.craig@nationwidechildrens.org
Study contacts (from the official record)
- Sardocor Corp. · +1-617-880-7616 · info@sardocorcorp.com
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