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

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.

Conditions

Heart Failure, Diastolic, Heart Failure With Preserved Ejection Fraction

Study Overview

Study Details

Study overview

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.

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

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

Condition
Heart Failure, Diastolic
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University, Durham, North Carolina, United States, 27705

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75390

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Willing and able to provide informed consent
  • * Negative for anti-AAV1 neutralizing antibodies
  • * NYHA class II or III
  • * Left ventricular ejection fraction ≥ 50%
  • * Evidence of resting or exercise-induced left ventricle filling pressure
  • * On oral diuretic therapy
  • * Adequate birth control
  • * NYHA class IV
  • * Heart failure requiring hospitalization in the past 3 months
  • * Manifested or provocable ischemic heart disease
  • * Atrial fibrillation
  • * History of congenital heart disease, restrictive or infiltrative cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm
  • * History of amyloidosis
  • * Untreated left-sided valvular disease
  • * Severe COPD
  • * BMI \> 50 kg/m\^2
  • * Severe liver, kidney or hematologic dysfunction
  • * Cancer within the past 5 years
  • * Unstable concurrent conditions

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sardocor Corp.,

Study Record Dates

2029-08