Recruiting
Phase 1

SERCA2a

Sponsor:

Sardocor Corp.

Code:

NCT06061549

Conditions

Heart Failure, Diastolic

Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

AAV1/SERCA2a

Study Details

Brief summary:

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 ID

NCT06061549

Start date

Aug 24, 2023

Status verified date

Sep, 2023

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SRD-001 Gene Therapy

AAV1/SERCA2a 3E13 vg

Interventions

AAV1/SERCA2a

3E13 viral genomes fixed dose

Primary outcome measure

  • Change in pulmonary capillary wedge pressure (PCWP) [ Time Frame: Week 24 and Week 52 ]

Central Contacts and Locations

Central contacts

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

More Information

Sponsor

Sardocor Corp.

Last update posted

Sep 29, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sardocor Corp. on 2023-09-29.