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NCT04945707 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Heart Failure With Preserved Ejection Fraction and Iron-deficiency, sponsored by Massachusetts General Hospital.

Recruiting
Registry status
Phase 4
Development phase
66
Enrollment target
1
Study location

NCT04945707: Recruiting Phase 4 study of Heart Failure With Preserved Ejection Fraction and Iron-deficiency, sponsored by Massachusetts General Hospital.

NCT04945707 is a Phase 4 study of Heart Failure With Preserved Ejection Fraction and Iron-deficiency that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 66 participants, below the 2,287-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04945707, a Phase 4 study of Heart Failure With Preserved Ejection Fraction and Iron-deficiency, is actively recruiting participants, sponsored by Massachusetts General Hospital.

RECRUITING
Registry status
Phase 4
Development phase
66 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

Peak VO2 measured by a maximal effort Cardiopulmonary Exercise Test (CPET)

Interventions

  • DRUG Placebo
  • DRUG Ferric Derisomaltose 1000 Mg in 100 mL INTRAVENOUS SOLUTION [Monoferric]

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2021-11-26
Est. Completion 2026-07-31
Phase Phase 4
Massachusetts General Hospital

2,032 total trials

What NCT04945707 shows while recruiting

NCT04945707 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 2,287-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (97% lower).

The record links to 2 conditions, with Heart Failure With Preserved Ejection Fraction appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04945707 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04945707 about?

NCT04945707 is a clinical study titled "Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF)". 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 mea...

What is the current status of trial NCT04945707?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 66 participants. The study started on 2021-11-26. Estimated completion is 2026-07-31.

What conditions does trial NCT04945707 study?

This clinical trial studies the following conditions: Heart Failure With Preserved Ejection Fraction, Iron-deficiency.

What interventions are being tested in trial NCT04945707?

The interventions under investigation include: Placebo (DRUG), Ferric Derisomaltose 1000 Mg in 100 mL INTRAVENOUS SOLUTION [Monoferric] (DRUG).

Who is sponsoring clinical trial NCT04945707?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04945707 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Heart Failure With Preserved Ejection Fraction

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04945707's enrollment target sits among peer trials

66 23rd of 42 higher than 20 of 42 other Heart Failure With Preserved Ejection Fraction trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Heart Failure With Preserved Ejection Fraction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04945707, the US trial registry maintained by the National Library of Medicine. NCT04945707 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.