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

Part of paid clinical trials in San Diego, California.

Sponsor
Sardocor Corp.
Study ID
NCT04703842
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • SRD-001 — BIOLOGICAL
    AAV1/SERCA2a
  • Placebo — DRUG
    SRD-001 matching placebo

Study Details

It is believed that targeted SERCA2a enzyme replacement in HFrEF patients will correct defective intracellular Ca2+ hemostasis, resulting in improved cardiac contractile function and energetics which will, in turn, translate to improved clinical outcomes. Additionally, it is hypothesized that correcting SERCA2a dysfunction will also improve coronary blood flow through correction of the impaired endothelium-dependent nitric oxide-mediated vasodilatation observed in heart failure.

Key Dates

Start date
Sep 23, 2021
Status verified
Mar 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2028

Study Design

Enrollment
57 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SRD-001
    3E13 or 4.5E13 vg; one-time intracoronary infusion
  • Placebo Comparator: Placebo
    One-time intracoronary infusion

Primary Outcome Measure

Change from baseline in symptomatic parameters [ Time Frame: Baseline to Month 6 and Month 12 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
San Diego Cardiac CenterSan DiegoCalifornia92123
Emma Burkhalter, RN
[email protected]
858-244-6890
Brian Jaski, MD (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
Kaye Reambonanza
[email protected]
415-514-6147
Richard Cheng, MD (PRINCIPAL_INVESTIGATOR)
Washington University in Saint LouisSt LouisMissouri63110
Annie Dirks, RN, BSN
[email protected]
314-454-8711
Gregory Ewald, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Therese Villina, MPHI, BSN
[email protected]
214-645-7083
Justin Grodin, MD (PRINCIPAL_INVESTIGATOR)
University of Washington MedicineSeattleWashington98195
Katherine Nassans
[email protected]
206-543-6850
Kenta Nakamura, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
San Diego Cardiac Center· San Diego, CAUniversity of California, San Francisco· San Francisco, CAWashington University in Saint Louis· St Louis, MOUniversity of Texas Southwestern Medical Center· Dallas, TXUniversity of Washington Medicine· Seattle, WA

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