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RecruitingPhase 1/Phase 2

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

Sardocor Corp. · NCT04703842

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
57
US sites recruiting
5
Study start
September 23, 2021
Record last updated
March 26, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: SRD-001; Placebo

Conditions: Congestive Heart Failure; Heart Failure, Systolic; Heart Failure; HFrEF - Heart Failure With Reduced Ejection Fraction

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • San Diego Cardiac Center

    San Diego, CA 92123

    Site contact: Emma Burkhalter, RN · 858-244-6890 · eburkhalter@sdcardiac.com

  • University of California, San Francisco

    San Francisco, CA 94143

    Site contact: Kaye Reambonanza · 415-514-6147 · Kaye.Reambonanza@ucsf.edu

  • Washington University in Saint Louis

    St Louis, MO 63110

    Site contact: Annie Dirks, RN, BSN · 314-454-8711 · aplatts@wustl.edu

  • University of Texas Southwestern Medical Center

    Dallas, TX 75390

    Site contact: Therese Villina, MPHI, BSN · 214-645-7083 · Therese.Vallina@utsouthwestern.edu

  • University of Washington Medicine

    Seattle, WA 98195

    Site contact: Katherine Nassans · 206-543-6850 · Knassans@uw.edu

Study contacts (from the official record)

  • COO · 858-752-2941 · info@sardocorcorp.com
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Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in… (NCT04703842) | Bored Studies