Heart Failure Clinical Trial
— MUSIC-HFrEF1Official title:
A Phase 1/2 Trial of the Safety and Efficacy of SRD-001 (AAV1/SERCA2a) in Subjects With Heart Failure With Reduced Ejection Fraction
Verified date | March 2024 |
Source | Sardocor Corp. |
Contact | COO |
Phone | 858-752-2941 |
info[@]sardocorcorp.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 57 |
Est. completion date | December 2028 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Main Inclusion Criteria: - Chronic ischemic or non-ischemic cardiomyopathy - NYHA class III/IV - LVEF =35% - Guideline-directed medical therapy for heart failure; ICD Main Exclusion Criteria: - Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm - 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 - Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, conventional revascularization procedure or valvular repair in the 6 months following treatment - Likely need for an immediate heart transplant or MCSD implant due to hemodynamic instability - Inadequate hepatic and renal function - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Washington University in Saint Louis | Saint Louis | Missouri |
United States | San Diego Cardiac Center | San Diego | California |
United States | University of California, San Francisco | San Francisco | California |
United States | University of Washington Medicine | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Sardocor Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in symptomatic parameters | New York Heart Association classification (I, II, III or IV) | Baseline to Month 6 and Month 12 | |
Primary | Change from baseline in symptomatic parameters | Quality of life as assessed by Kansas City Cardiomyopathy Questionnaire: 0-24, very poor to poor; 25-49, poor to fair; 50-74, fair to good; and 75-100, good to excellent | Baseline to Month 6 and Month 12 | |
Primary | Change from baseline in physical parameter | Distance walked during the 6MWT | Baseline to Month 6 and Month 12 | |
Primary | Change from baseline in LV function/remodeling | Left ventricular end systolic volume (LVESV) as assessed by echocardiography | Baseline to Month 6 and Month 12 | |
Primary | Rate of recurrent events | HF-related hospitalization, ambulatory worsening heart failure, all-cause death, MCSD and transplant | Baseline to Month 6 and Month 12 | |
Primary | Rate of adverse events | Treatment-emergent adverse events | 6 and 12 months | |
Secondary | Proportion of subjects who complete the trial | Those who complete the trial vs withdraw consent, are lost to follow-up, or withdrawn due to an AE or other reason | 12 months | |
Secondary | Concomitant medication use | Changes in heart failure related medications | 6 and 12 months | |
Secondary | Incidence of abnormal laboratory test results | Hematologic, serum chemistries, NT-proBNP and troponin | Baseline to Month 6 and Month 12 | |
Secondary | Incidence of abnormal ECG results | New arrhythmias | Baseline to Month 6 and Month 12 | |
Secondary | Incidence of abnormal physical examination findings | Change from baseline in physical examination findings | Baseline to Month 6 and Month 12 | |
Secondary | Incidence of abnormal findings from interrogation of implantable cardioverter defibrillator | New arrhythmias | Baseline to Month 6 and Month 12 |
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