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RECRUITING
NCT06061549
PHASE1

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

Sponsor: Sardocor Corp.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2023-08-24

Completion Date

2029-08

Last Updated

2023-09-29

Healthy Volunteers

No

Interventions

BIOLOGICAL

AAV1/SERCA2a

3E13 viral genomes fixed dose

Locations (2)

Duke University

Durham, North Carolina, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States