RECRUITING

Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved 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

The goal of this clinical trial is to test an experimental gene therapy in participants with heart failure with preserved ejection fraction, also known as diastolic heart failure. The main questions it aims to answer are: * safety and tolerability of the gene therapy; and * whether the gene therapy helps the heart ventricles relax during filling. Participants will undergo a one-time infusion of the gene therapy in the cardiac catheterization laboratory and then be followed for safety and effects on left-sided filling pressures while exercising. The first year will have multiple in-person visits followed by 4 years of biannual phone calls.

Official Title

A Phase 1b, Pilot Trial Evaluating the Safety and Pharmacodynamic Effects of SRD-001 (AAV1-SERCA2a) in Subjects With Heart Failure With Preserved Ejection Fraction

Quick Facts

Study Start:2023-08-24
Study Completion:2029-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06061549

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:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to provide informed consent
  2. * Negative for anti-AAV1 neutralizing antibodies
  3. * NYHA class II or III
  4. * Left ventricular ejection fraction ≥ 50%
  5. * Evidence of resting or exercise-induced left ventricle filling pressure
  6. * On oral diuretic therapy
  7. * Adequate birth control
  1. * NYHA class IV
  2. * Heart failure requiring hospitalization in the past 3 months
  3. * Manifested or provocable ischemic heart disease
  4. * Atrial fibrillation
  5. * History of congenital heart disease, restrictive or infiltrative cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm
  6. * History of amyloidosis
  7. * Untreated left-sided valvular disease
  8. * Severe COPD
  9. * BMI \> 50 kg/m\^2
  10. * Severe liver, kidney or hematologic dysfunction
  11. * Cancer within the past 5 years
  12. * Unstable concurrent conditions

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Duke University
Durham, North Carolina, 27705
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
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 Date2023-08-24
Study Completion Date2029-08

Study Record Updates

Study Start Date2023-08-24
Study Completion Date2029-08

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure, Diastolic
  • Heart Failure With Preserved Ejection Fraction