NCT07634640

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for early_phase_1

Timeline
12mo left

Started Nov 2023

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Nov 2023May 2027

Study Start

First participant enrolled

November 3, 2023

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

June 9, 2026

Status Verified

May 1, 2026

Enrollment Period

3.6 years

First QC Date

June 4, 2026

Last Update Submit

June 4, 2026

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Keywords

heart failure with preserved ejection fraction

Outcome Measures

Primary Outcomes (1)

  • detection of inflammation

    72 hours

Study Arms (1)

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

Drug: Ferumoxytol infusion

Interventions

Ferumoxytol infusionDRUG

Ferumoxytol infusion followed by cardiac MRI

Single arm study of subjects with HFpEF

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HFpEF

You may not qualify if:

  • Renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

Study Officials

  • Ellen C Keeley, MD, MS

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen C Keeley, MD, MS

CONTACT

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

Vanessa H Scheuble

CONTACT

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

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 9, 2026

Study Start

November 3, 2023

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

June 9, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)