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RecruitingPhase 1

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

Sardocor Corp. · NCT06061549

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 50+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
10
US sites recruiting
1
Study start
August 24, 2023
Record last updated
September 29, 2023

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: AAV1/SERCA2a

Conditions: Heart Failure, Diastolic; Heart Failure With Preserved Ejection Fraction

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Duke University

    Durham, NC 27705

    Site contact: Kay Doukellis · katheryn.doukellis@duke.edu

Study contacts (from the official record)

  • Sardocor · 858-752-2941 · info@sardocorcorp.com
All heart & blood pressure studies in North Carolina →
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in… (NCT06061549) | Bored Studies