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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 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.
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ferric Derisomaltose 1000 Mg in 100 mL INTRAVENOUS SOLUTION [Monoferric]
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2021-11-26 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04945707
The ClinicalTrials.gov registry entry for NCT04945707 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,287-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (97% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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