[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sardocor Corp.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100533349","phase-1-modulation-of-serca2a-of-intra-myocytic-calcium-trafficking-in-cardiomyopathy-secondary-to-duchenne-muscular-dystrophy-100533349",false,"NCT06224660","Modulation of SERCA2a of Intra-Myocytic Calcium Trafficking in Cardiomyopathy Secondary to Duchenne Muscular Dystrophy","A Phase 1b, Open-Label, Controlled Trial Evaluating the Safety and Efficacy of SRD-001 (AAV1\u002FSERCA2a) in Subjects With Cardiomyopathy Secondary to Duchenne Muscular Dystrophy","MUSIC-DMD","Inclusion Criteria:\n\n* Diagnosis of DMD with confirmatory genetic testing\n* Cardiomyopathy with left ventricular scar in at least 3 of 16 segments\n* Left ventricular ejection fraction \\\u003C 40%\n* Individualized, optimized cardiac medical therapy and glucocorticoid treatment for at least 12 months prior to enrollment\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Abnormal blood pressure\n* Non-DMD-related liver function test elevations\n* Cystatin C ≥ 1.2 mg\u002FL\n* Thrombocytopenia\n* Anemia\n* Inadequate pulmonary function","MALE","18 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","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\u002Fcontract 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.",[27],"DMD-Associated Dilated Cardiomyopathy","RECRUITING","2025-02-26",{"date":31,"type":32},"2025-02-27","ACTUAL",{"date":34,"type":32},"2024-10-02",{"date":36,"type":21},"2030-10",{"name":38,"class":39},"Sardocor Corp.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100416528","phase-1-modulation-of-serca2a-of-intra-myocytic-calcium-trafficking-in-heart-failure-with-reduced-ejection-fraction-100416528","NCT04703842","Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction","A Phase 1\u002F2 Trial of the Safety and Efficacy of SRD-001 (AAV1\u002FSERCA2a) in Subjects With Heart Failure With Reduced Ejection Fraction","MUSIC-HFrEF1","Main Inclusion Criteria:\n\n* Chronic ischemic or non-ischemic cardiomyopathy\n* NYHA class III\u002FIV\n* LVEF ≤35%\n* Guideline-directed medical therapy for heart failure; ICD\n\nMain Exclusion Criteria:\n\n* Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm\n* Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), mechanical circulatory support device (MCSD) or cardiac shunt\n* Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, conventional revascularization procedure or valvular repair in the 6 months following treatment\n* Likely need for an immediate heart transplant or MCSD implant due to hemodynamic instability\n* Inadequate hepatic and renal function\n* Diagnosis of, or treatment for, any cancer within the last 5 years except for basal cell carcinoma or carcinomas in situ where surgical excision was considered curative","ALL","80 Years",{"count":51,"type":21},57,[24,53],"PHASE2","It is believed that targeted SERCA2a enzyme replacement in HFrEF patients will correct defective intracellular Ca2+ hemostasis, resulting in improved cardiac contractile function and energetics which will, in turn, translate to improved clinical outcomes. Additionally, it is hypothesized that correcting SERCA2a dysfunction will also improve coronary blood flow through correction of the impaired endothelium-dependent nitric oxide-mediated vasodilatation observed in heart failure.",[56,57,58,59],"Congestive Heart Failure","Heart Failure, Systolic","Heart Failure","HFrEF - Heart Failure With Reduced Ejection Fraction","2024-03-24",{"date":62,"type":32},"2024-03-26",{"date":64,"type":32},"2021-09-23",{"date":66,"type":21},"2028-12",{"name":38,"class":39},5,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":48,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100520821","phase-1-modulation-of-serca2a-of-intra-myocytic-calcium-trafficking-in-heart-failure-with-preserved-ejection-fraction-100520821","NCT06061549","Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction","A Phase 1b, Pilot Trial Evaluating the Safety and Pharmacodynamic Effects of SRD-001 (AAV1-SERCA2a) in Subjects With Heart Failure With Preserved Ejection Fraction","MUSIC-HFpEF","Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Negative for anti-AAV1 neutralizing antibodies\n* NYHA class II or III\n* Left ventricular ejection fraction ≥ 50%\n* Evidence of resting or exercise-induced left ventricle filling pressure\n* On oral diuretic therapy\n* Adequate birth control\n\nExclusion Criteria:\n\n* NYHA class IV\n* Heart failure requiring hospitalization in the past 3 months\n* Manifested or provocable ischemic heart disease\n* Atrial fibrillation\n* History of congenital heart disease, restrictive or infiltrative cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm\n* History of amyloidosis\n* Untreated left-sided valvular disease\n* Severe COPD\n* BMI \\> 50 kg\u002Fm\\^2\n* Severe liver, kidney or hematologic dysfunction\n* Cancer within the past 5 years\n* Unstable concurrent conditions","50 Years",{"count":79,"type":21},10,[24],"The goal of this clinical trial is to test an experimental gene therapy in participants with heart failure with preserved ejection fraction, also known as diastolic heart failure. The main questions it aims to answer are:\n\n* safety and tolerability of the gene therapy; and\n* whether the gene therapy helps the heart ventricles relax during filling. Participants will undergo a one-time infusion of the gene therapy in the cardiac catheterization laboratory and then be followed for safety and effects on left-sided filling pressures while exercising. The first year will have multiple in-person visits followed by 4 years of biannual phone calls.",[83,84],"Heart Failure, Diastolic","Heart Failure With Preserved Ejection Fraction","2023-09-23",{"date":87,"type":32},"2023-09-29",{"date":89,"type":32},"2023-08-24",{"date":91,"type":21},"2029-08",{"name":38,"class":39},2,""]