NCT07686692

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
49mo left

Started Aug 2026

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

June 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

4 years

First QC Date

June 30, 2026

Last Update Submit

June 30, 2026

Conditions

Heart Failure With Preserved Ejection FractionIron Deficiency

Keywords

Heart Failure with Preserved Ejection FractionIron DeficiencyFerric Derisomaltose

Outcome Measures

Primary Outcomes (1)

  • Hierarchical composite of mortality, all-cause hospitalization, and ≥5-point KCCQ-12 improvement.

    6 months

Secondary Outcomes (1)

  • 6-MWT

    6 months

Study Arms (2)

Ferric Derisomaltose

EXPERIMENTAL
Drug: Ferric derisomaltose

Placebo

PLACEBO COMPARATOR
Drug: Placebo (normal saline)

Interventions

Ferric derisomaltoseDRUG

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.

Ferric Derisomaltose
Placebo (normal saline)DRUG

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.

Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferric derisomaltoseSaline Solution

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Marat Fudim

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)