NCT06061549RecruitingPhase 1
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction
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
Source: ClinicalTrials.gov · Last updated 29 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 30 Jul 2023
- Start date
- 24 Aug 2023
- Primary completion date
- Aug 2025
- Lead sponsor
- Sardocor Corp.
- Diseases
- Heart failure
- NCT number
- NCT06061549
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 24 Aug 2023 to the primary completion date, Aug 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unstable concurrent conditions
Other illness
- Heart failure requiring hospitalization in the past 3 months
- Manifested or provocable ischemic heart disease
- 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
- Cancer within the past 5 years
Other
- NYHA class IV
- Atrial fibrillation
- Severe COPD
- BMI \> 50 kg/m\^2
- Severe liver, kidney or hematologic dysfunction
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Not yet recruiting |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.