Hearts on Fire: Targeting Inflammation in Heart Failure With Preserved Ejection Fraction

June 4, 2026 updated by: University of Florida

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • HFpEF

Exclusion Criteria:

  • Renal insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm study of subjects with HFpEF
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
Drug: Ferumoxytol infusion
Ferumoxytol infusion followed by cardiac MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
detection of inflammation
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

American Heart Association

Investigators

  • Principal Investigator: Ellen C Keeley, MD, MS, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2023

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202300847
  • 26BIPA1622606 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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