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NCT06061549 · ClinicalTrials.gov registry record · Phase 1
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction
A Phase 1 study of Heart Failure With Preserved Ejection Fraction and Heart Failure, Diastolic, sponsored by Sardocor.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT06061549 is a Phase 1 study of Heart Failure With Preserved Ejection Fraction and Heart Failure, Diastolic that is actively recruiting participants, run by Sardocor. The registered enrollment target is 10 participants, below the 2,288-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06061549, a Phase 1 study of Heart Failure With Preserved Ejection Fraction and Heart Failure, Diastolic, is actively recruiting participants, sponsored by Sardocor.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- BIOLOGICAL AAV1/SERCA2a
Study Locations (2)
North Carolina
- Duke University - Durham
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-08-24 |
| Est. Completion | 2029-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06061549
The ClinicalTrials.gov registry entry for NCT06061549 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,288-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (100% lower). The listed sponsor is Sardocor, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Heart Failure With Preserved Ejection Fraction appearing as the primary indexed condition, and to 1 intervention - of which AAV1/SERCA2a is the first listed.
NCT06061549 reports 2 study locations spanning 2 distinct geographic areas - top geographies include North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT06061549 about?
NCT06061549 is a clinical study titled "Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction". 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...
What is the current status of trial NCT06061549?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-08-24. Estimated completion is 2029-08.
What conditions does trial NCT06061549 study?
This clinical trial studies the following conditions: Heart Failure With Preserved Ejection Fraction, Heart Failure, Diastolic.
What interventions are being tested in trial NCT06061549?
The interventions under investigation include: AAV1/SERCA2a (BIOLOGICAL).
Who is sponsoring clinical trial NCT06061549?
This trial is sponsored by Sardocor, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06061549 being conducted?
This trial has 2 study locations across North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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