Heart Failure With Preserved Ejection Fraction (HFPEF)Early Phase 1NCT07634640
Hearts on Fire: Targeting Inflammation in Heart Failure With Preserved Ejection Fraction
A Early Phase 1 study testing Ferumoxytol infusion in people with Heart Failure With Preserved Ejection Fraction (HFPEF), run by University of Florida at 1 site in United States.
Trial summary
Subjects undergo a gadolinium-based CMR followed by an iron infusion and then a repeat CMR in 72 hours Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFPEF)
- What is being tested?
- Ferumoxytol infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2023to 31 May 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HFpEF
Who cannot join
- Renal insufficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32608
Ellen C Keeley, MD, MS, 800-265-0820, ellen.keeley@medicine.ufl.edu
About this study
Official title: Omega-3 Fatty Acids and Myocardial Inflammation in HFpEF: Preliminary Data and Next Steps
Subjects undergo a gadolinium-based CMR followed by an iron infusion and then a repeat CMR in 72 hours
- Being tested
- Ferumoxytol infusion
- Keywords
- heart failure with preserved ejection fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferumoxytol infusionDrug
Ferumoxytol infusion followed by cardiac MRI
| Study group | Role | What they receive |
|---|---|---|
| Single arm study of subjects with HFpEF | Experimental | Subjects with HFpEF undergo a baseline gadolinium based cardiac MRI and the same day they undergo an iron infusion. Three days later they return for a follow-up cardiac MRI and the iron that has been administered 72 hours ago serves as the contrast media Receives: Drug: Ferumoxytol infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of inflammation
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start3 Nov 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFPEF)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Ellen C Keeley, MD, MS, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634640
- Sponsor's protocol ID
- 202300847
- Other IDs
- 26BIPA1622606
- Status last verified
- May 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids and Myocardial Inflammation in HFpEF: Preliminary Data and Next Steps
- ClinicalTrials.gov ID
- NCT07634640
- Acronym / sponsor ID
- 202300847
- Keywords
- heart failure with preserved ejection fraction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects undergo a gadolinium-based CMR followed by an iron infusion and then a repeat CMR in 72 hours
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study of subjects with HFpEF | Experimental | Drug: Ferumoxytol infusionSubjects with HFpEF undergo a baseline gadolinium based cardiac MRI and the same day they undergo an iron infusion. Three days later they return for a follow-up cardiac MRI and the iron that has been administered 72 hours ago serves as the contrast media |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HFpEF
Key exclusion criteria (1 listed)
- Renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferumoxytol infusionFerumoxytol infusion followed by cardiac MRI | Drug | Single arm study of subjects with HFpEF |
Primary outcome
detection of inflammation
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellen C Keeley, MD, MS principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ferumoxytol infusion in people with Heart Failure With Preserved Ejection Fraction (HFPEF), run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen C Keeley, MD, MS (800-265-0820, ellen.keeley@medicine.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of inflammation (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.