NCT06061549 Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction
| NCT ID | NCT06061549 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sardocor Corp. |
| Condition | Heart Failure, Diastolic |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-08-24 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2023-08-24 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06061549 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Heart Failure, Diastolic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06061549 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06061549 currently recruiting?
Yes, NCT06061549 is actively recruiting participants. Contact the research team at info@sardocorcorp.com for enrollment information.
Where is the NCT06061549 trial being conducted?
This trial is being conducted at Durham, United States, Dallas, United States.
Who is sponsoring the NCT06061549 clinical trial?
NCT06061549 is sponsored by Sardocor Corp.. The trial plans to enroll 10 participants.
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