RecruitingPhase 1Phase 2NCT04703842

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

A Phase 1/2 Trial of the Safety and Efficacy of SRD-001 (AAV1/SERCA2a) in Subjects With Heart Failure With Reduced Ejection Fraction


Sponsor

Sardocor Corp.

Enrollment

57 participants

Start Date

Sep 23, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a gene therapy approach that targets a protein called SERCA2a in the heart, which helps regulate calcium and allows the heart to beat properly. The goal is to see if this therapy can improve heart function in patients with severe, chronic heart failure. **You may be eligible if...** - You have chronic heart failure (ischemic or non-ischemic) with severely reduced heart pump function (LVEF ≤35%) - You are in NYHA class III or IV (significant symptoms with minimal or no activity) - You are already on maximum recommended heart failure medications and have an implanted defibrillator (ICD) **You may NOT be eligible if...** - You have a specific type of cardiomyopathy such as restrictive, hypertrophic, amyloidosis, or myocarditis - You have had a prior heart transplant or certain prior heart surgeries - You have uncontrolled thyroid disease - You have certain serious kidney, liver, or other organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSRD-001

AAV1/SERCA2a

DRUGPlacebo

SRD-001 matching placebo


Locations(5)

San Diego Cardiac Center

San Diego, California, United States

University of California, San Francisco

San Francisco, California, United States

Washington University in Saint Louis

St Louis, Missouri, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Washington Medicine

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT04703842


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