IV Iron Therapy for Heart Failure and Iron Deficiency

(INFUSE-HFpEF Trial)

Age: 65+
Sex: Any
Trial Phase: Phase 4
Sponsor: Duke University
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency.

Who Is on the Research Team?

MF

Marat Fudim

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for older adults who have heart failure with preserved ejection fraction (HFpEF) and are also low in iron. People with other major health issues or conditions that could interfere with the study may not be able to join.

Inclusion Criteria

TSAT <20%
I am 65 or older, can walk, and have heart failure with normal ejection fraction.
I have been hospitalized for heart failure in the past year.
See 1 more

Exclusion Criteria

I currently have an infection or inflammatory disease.
Pregnancy, breastfeeding, or planned pregnancy during the study period
My hemoglobin level is not within the normal range for my gender.
See 10 more

What Are the Treatments Tested in This Trial?

Interventions

  • Ferric derisomaltose

Trial Overview

The study is testing whether giving intravenous ferric derisomaltose (a type of iron given through a vein) helps people with HFpEF and iron deficiency, compared to a placebo (salt water). Participants are randomly assigned to one group or the other, and neither they nor their doctors know which treatment they're getting.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Ferric DerisomaltoseExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Kaiser Permanente

Collaborator

Trials
563
Recruited
27,400,000+