Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction

Launched by SARDOCOR CORP. · Sep 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying an experimental gene therapy aimed at helping people with heart failure with preserved ejection fraction, which is sometimes called diastolic heart failure. The main goals are to find out if this new therapy is safe and if it can improve the heart's ability to relax and fill with blood properly. Participants will receive a single infusion of the gene therapy during a procedure called cardiac catheterization, where doctors insert a thin tube into a blood vessel to deliver the treatment. Afterward, they will be monitored for a year with several in-person visits, then followed up with phone calls every six months for the next four years.

To join the study, participants need to be adults aged 18 to 262 who can give informed consent and meet certain health criteria. For example, they should have a specific level of heart function (left ventricular ejection fraction of 50% or higher) and experience some heart-related symptoms that affect their daily activities. However, people with more severe heart issues, recent hospitalizations, or certain other medical conditions will not be eligible. If you think this trial might be right for you or a loved one, it’s a good idea to discuss it with a healthcare provider for more details.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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