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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50+
SponsorSardocor Corp.

About this trial

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.

Eligibility criteria

Qualifiers

Willing and able to provide informed consent

Negative for anti-AAV1 neutralizing antibodies

NYHA class II or III

Left ventricular ejection fraction ≥ 50%

Disqualifiers

NYHA class IV

Heart failure requiring hospitalization in the past 3 months

Manifested or provocable ischemic heart disease

Atrial fibrillation

Trial design

Treatments tested in this trial

  • AAV1/SERCA2a

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators