Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 80Years
All Genders
NCT04703842

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

Led by Sardocor Corp. · Updated on 2024-03-26

57

Participants Needed

5

Research Sites

375 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chronic ischemic or non-ischemic cardiomyopathy
  • New York Heart Association (NYHA) class III or IV heart failure symptoms
  • Left ventricular ejection fraction (LVEF) of 35% or less
  • Receiving guideline-directed medical therapy for heart failure and have an implantable cardioverter defibrillator (ICD)
Not Eligible

You will not qualify if you...

  • Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or discrete left ventricular aneurysm
  • Prior heart transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device use, mechanical circulatory support device, or cardiac shunt
  • Likely to undergo cardiac resynchronization therapy, cardiomyoplasty, left ventricular reduction surgery, conventional revascularization, or valvular repair within 6 months after treatment
  • Expected need for immediate heart transplant or mechanical circulatory support due to hemodynamic instability
  • Inadequate liver or kidney function
  • Diagnosis or treatment for any cancer within the last 5 years except basal cell carcinoma or carcinoma in situ treated with surgery alone

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

San Diego Cardiac Center

San Diego, California, United States, 92123

Actively Recruiting

2

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

3

Washington University in Saint Louis

St Louis, Missouri, United States, 63110

Actively Recruiting

4

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

5

University of Washington Medicine

Seattle, Washington, United States, 98195

Actively Recruiting

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Research Team

C

COO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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