Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04945707
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ferric Derisomaltose 1000 Mg in 100 mL INTRAVENOUS SOLUTION [Monoferric] — DRUG
    Ferric derisomaltose (Monoferric) 1000 mg X1 (for subject \<50 kg, 20 mg/kg
  • Placebo — DRUG
    Normal saline

Study Details

The primary objective of this study is to determine if the correction of functional iron deficiency by administering a single dose of intravenous iron (ferric derimaltose or Monoferric®) in participants with heart failure with preserved ejection fraction (HFpEF) will improve exercise capacity as measured by the change in peak oxygen uptake (peak VO2) from baseline to 12 weeks.

Key Dates

Start date
Nov 26, 2021
Status verified
Feb 2026
Primary completion
Mar 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1
    Ferric derisomaltose (Monoferric®) 1000 mg X 1 (for subject \<50 kg, 20 mg/kg X1)
  • Placebo Comparator: Arm 2
    Normal Saline

Primary Outcome Measure

The change in peak oxygen uptake (peak VO2) from baseline to week 12 in HFpEF subjects with functional iron deficiency following a single dose of ferric derisomaltose or placebo. [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Greg Lewis, MD
[email protected]
6177249254
Diane Cocca-Spofford, BSN
[email protected]
617 726 8228

Find similar trials in Boston, MA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Massachusetts General Hospital· Boston, MA

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