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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Sardocor Corp.
Study ID
NCT06061549
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AAV1/SERCA2a — BIOLOGICAL
    3E13 viral genomes fixed dose

Study Details

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.

Key Dates

Start date
Aug 24, 2023
Status verified
Sep 2023
Primary completion
Aug 31, 2025
Completion
Aug 31, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SRD-001 Gene Therapy
    AAV1/SERCA2a 3E13 vg

Primary Outcome Measure

Change in pulmonary capillary wedge pressure (PCWP) [ Time Frame: Week 24 and Week 52 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27705
Kay Doukellis
[email protected]
University of Texas Southwestern Medical CenterDallasTexas75390
Therese Vallina
[email protected]

Find similar trials in Durham, NC

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Duke University· Durham, NCUniversity of Texas Southwestern Medical Center· Dallas, TX

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