Status:
RECRUITING
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
Sardocor Corp.
Conditions:
Heart Failure, Diastolic
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
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 i...
Detailed Description
Eligible participants will undergo a one-time antegrade epicardial coronary artery infusion of gene therapy delivered to the 3 major cardiac territories of the left ventricle of the heart (anterior, l...
Eligibility Criteria
Inclusion
- Willing and able to provide informed consent
- Negative for anti-AAV1 neutralizing antibodies
- NYHA class II or III
- Left ventricular ejection fraction ≥ 50%
- Evidence of resting or exercise-induced left ventricle filling pressure
- On oral diuretic therapy
- Adequate birth control
Exclusion
- NYHA class IV
- Heart failure requiring hospitalization in the past 3 months
- Manifested or provocable ischemic heart disease
- Atrial fibrillation
- History of congenital heart disease, restrictive or infiltrative cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm
- History of amyloidosis
- Untreated left-sided valvular disease
- Severe COPD
- BMI \> 50 kg/m\^2
- Severe liver, kidney or hematologic dysfunction
- Cancer within the past 5 years
- Unstable concurrent conditions
Key Trial Info
Start Date :
August 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06061549
Start Date
August 24 2023
End Date
August 1 2029
Last Update
September 29 2023
Active Locations (2)
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1
Duke University
Durham, North Carolina, United States, 27705
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390