Recruiting
Early Phase 1

Iron Infusion

Sponsor:

University of Florida

Code:

NCT07634640

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ferumoxytol infusion

Study Details

Brief summary:

Subjects undergo a gadolinium-based CMR followed by an iron infusion and then a repeat CMR in 72 hours

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Study ID

NCT07634640

Start date

Nov 3, 2023

Status verified date

May, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • HFpEF

Exclusion Criteria:

  • Renal insufficiency

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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

Interventions

Ferumoxytol infusion

Ferumoxytol infusion followed by cardiac MRI

Primary outcome measure

  • detection of inflammation [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

Ellen C Keeley, MD, MS

800-265-0820ellen.keeley@medicine.ufl.edu

Vanessa H Scheuble

800-555-0820Vanessa.scheuble@medicine.ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Ellen C Keeley, MD, MS

800-265-0820ellen.keeley@medicine.ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Jun 9, 2026

Last verified

May, 2026

Keywords

  • heart failure with preserved ejection fraction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-09.