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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: Recruiting Phase 1 study of Heart Failure With Preserved Ejection Fraction and Heart Failure, Diastolic, sponsored by Sardocor.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PCWP assessed by right heart catheterization; change in mmHg from baseline
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 |
What NCT06061549 shows while recruiting
NCT06061549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 2,288-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Heart Failure With Preserved Ejection Fraction
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06061549's enrollment target sits among peer trials
10 41st of 42 higher than 1 of 42 other Heart Failure With Preserved Ejection Fraction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure With Preserved Ejection Fraction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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