RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-09-23
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04703842

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Chronic ischemic or non-ischemic cardiomyopathy
  2. * NYHA class III/IV
  3. * LVEF ≤35%
  4. * Guideline-directed medical therapy for heart failure; ICD
  1. * Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm
  2. * 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
  3. * Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, conventional revascularization procedure or valvular repair in the 6 months following treatment
  4. * Likely need for an immediate heart transplant or MCSD implant due to hemodynamic instability
  5. * Inadequate hepatic and renal function
  6. * 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

Contacts and Locations

Study Contact

COO
CONTACT
858-752-2941
info@sardocorcorp.com

Study Locations (Sites)

San Diego Cardiac Center
San Diego, California, 92123
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Washington University in Saint Louis
Saint Louis, Missouri, 63110
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
University of Washington Medicine
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Sardocor Corp.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-23
Study Completion Date2028-12

Study Record Updates

Study Start Date2021-09-23
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Congestive Heart Failure
  • Heart Failure, Systolic
  • Heart Failure
  • HFrEF - Heart Failure With Reduced Ejection Fraction