A Phase 1b, Pilot Trial Evaluating the Safety and Pharmacodynamic Effects of SRD-001 (AAV1-SERCA2a) in Subjects With Heart Failure With Preserved Ejection Fraction

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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 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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
Duke University
RECRUITING
Durham
Texas
University of Texas Southwestern Medical Center
NOT_YET_RECRUITING
Dallas
Contact Information
Primary
Sardocor
info@sardocorcorp.com
858-752-2941
Time Frame
Start Date: 2023-08-24
Estimated Completion Date: 2029-08
Participants
Target number of participants: 10
Treatments
Experimental: SRD-001 Gene Therapy
AAV1/SERCA2a 3E13 vg
Sponsors
Leads: Sardocor Corp.

This content was sourced from clinicaltrials.gov