Actively Recruiting
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction
Led by Sardocor Corp. · Updated on 2023-09-29
10
Participants Needed
2
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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: * safety and tolerability of the gene therapy; and * 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.
CONDITIONS
Official Title
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- Negative for anti-AAV1 neutralizing antibodies
- NYHA class II or III heart failure
- Left ventricular ejection fraction 50% or higher
- Evidence of resting or exercise-induced left ventricle filling pressure
- Currently on oral diuretic therapy
- Adequate birth control for participants
You will not qualify if you...
- NYHA class IV heart failure
- Heart failure hospitalization within the past 3 months
- Manifest or inducible 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 aneurysm
- History of amyloidosis
- Untreated left-sided valvular disease
- Severe chronic obstructive pulmonary disease
- Body mass index over 50 kg/m2
- Severe liver, kidney, or blood disorders
- Cancer diagnosis within the past 5 years
- Unstable concurrent medical conditions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Not Yet Recruiting
Research Team
S
Sardocor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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