IV Iron Therapy for Older Adults With Heart Failure With Preserved Ejection Fraction and Iron Deficiency (INFUSE-HFpEF)

June 30, 2026 updated by: Duke University

Iron Needed for Function and Undesirable Symptoms in Elderly With Heart Failure With Preserved Ejection Fraction

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Health System

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

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ambulatory adults age >=65 years with HFpEF (EF >50%)
  • Hospitalized for HF in the past 12 months
  • TSAT <20%
  • Able to walk without assistance

Exclusion Criteria:

  • Alternative etiologies of HFpEF syndrome:
  • Uncorrected severe valvular heart disease
  • Constrictive pericarditis
  • High output HF
  • Infiltrative cardiomyopathy
  • Safety concerns for participation
  • Known hypersensitivity/allergy to any IV iron formulation
  • History of iron overload (i.e., hemochromatosis)
  • Hemoglobin <9 g/dL or >13.5 (women)/>15.0 (men) g/dL
  • Hospitalized for GI bleed in past 12 months
  • Active infection or inflammatory disease
  • Severe liver disease (i.e., active hepatitis or known cirrhosis)
  • Current or recent use (4 weeks) of IV iron therapy
  • Severe renal impairment (i.e., eGFR <15 mL/min/1.73 m2 or Chronic Kidney Disease on dialysis)
  • Estimated life expectancy <6 months
  • Unable to provide informed consent
  • Pregnancy, breastfeeding, or planned pregnancy during the study period
  • Current participation in another investigational drug or device study; or participation in such a study within 30 days prior to baseline

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo (normal saline)
To preserve blinding, the normal saline placebo dose is also determined by participant body weight and baseline hemoglobin and ranges from 500 mg to 2000 mg, administered as a single infusion.
Experimental: Ferric Derisomaltose
Drug: Ferric derisomaltose
Intravenous ferric derisomaltose dose is determined by participant body weight and baseline hemoglobin and ranges from 500 mg to 2000 mg, administered as a single infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hierarchical composite of mortality, all-cause hospitalization, and ≥5-point KCCQ-12 improvement.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
6-MWT
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Duke University

Collaborators

National Institutes of Health (NIH)
National Institute on Aging (NIA)
Kaiser Permanente

Investigators

  • Principal Investigator: Marat Fudim, Duke University

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 (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00119548
  • 1R01AG097715 (U.S. NIH Grant/Contract)

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

product manufactured in and exported from the U.S.

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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