Recruiting
Phase 1
Phase 2

SERCA2a

Sponsor:

Sardocor Corp.

Code:

NCT04703842

Conditions

Congestive Heart Failure

Heart Failure, Systolic

Heart Failure

HFrEF - Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SRD-001

Placebo

Study Details

Brief summary:

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.

Conditions

Congestive Heart Failure

Heart Failure, Systolic

Heart Failure

HFrEF - Heart Failure With Reduced Ejection Fraction

Study ID

NCT04703842

Start date

Sep 23, 2021

Status verified date

Mar, 2024

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Main Inclusion Criteria:

  • Chronic ischemic or non-ischemic cardiomyopathy
  • NYHA class III/IV
  • LVEF ≤35%
  • Guideline-directed medical therapy for heart failure; ICD

Main Exclusion Criteria:

  • Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm
  • Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), mechanical circulatory support device (MCSD) or cardiac shunt
  • Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, conventional revascularization procedure or valvular repair in the 6 months following treatment
  • Likely need for an immediate heart transplant or MCSD implant due to hemodynamic instability
  • Inadequate hepatic and renal function
  • Diagnosis of, or treatment for, any cancer within the last 5 years except for basal cell carcinoma or carcinomas in situ where surgical excision was considered curative

Study Design

Enrollment

57 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SRD-001

3E13 or 4.5E13 vg; one-time intracoronary infusion

placebo comparator: Placebo

One-time intracoronary infusion

Interventions

SRD-001

AAV1/SERCA2a

Placebo

SRD-001 matching placebo

Primary outcome measure

  • Change from baseline in symptomatic parameters [ Time Frame: Baseline to Month 6 and Month 12 ]
  • Change from baseline in symptomatic parameters [ Time Frame: Baseline to Month 6 and Month 12 ]
  • Change from baseline in physical parameter [ Time Frame: Baseline to Month 6 and Month 12 ]
  • Change from baseline in LV function/remodeling [ Time Frame: Baseline to Month 6 and Month 12 ]
  • Rate of recurrent events [ Time Frame: Baseline to Month 6 and Month 12 ]
  • Rate of adverse events [ Time Frame: 6 and 12 months ]

Central Contacts and Locations

Central contacts

COO

858-752-2941info@sardocorcorp.com

Locations

San Diego Cardiac Center

Recruiting

San Diego, California, United States, 92123

Contacts

Emma Burkhalter, RN

858-244-6890eburkhalter@sdcardiac.com

Principal Investigator:

Brian Jaski, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Kaye Reambonanza

415-514-6147Kaye.Reambonanza@ucsf.edu

Principal Investigator:

Richard Cheng, MD

Washington University in Saint Louis

Recruiting

Saint Louis, Missouri, United States, 63110

Contacts

Annie Dirks, RN, BSN

314-454-8711aplatts@wustl.edu

Principal Investigator:

Gregory Ewald, MD

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Therese Villina, MPHI, BSN

214-645-7083Therese.Vallina@utsouthwestern.edu

Principal Investigator:

Justin Grodin, MD

University of Washington Medicine

Recruiting

Seattle, Washington, United States, 98195

Contacts

Katherine Nassans

206-543-6850Knassans@uw.edu

Principal Investigator:

Kenta Nakamura, MD

More Information

Sponsor

Sardocor Corp.

Last update posted

Mar 26, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sardocor Corp. on 2024-03-26.