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Iron Deficiency / Ferric Derisomaltose 1000 Mg in 100 mL INTRAVENOUS SOLUTION [Monoferric] / Heart Failure With Preserved Ejection Fraction · Phase 4 Trial
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 4 clinical trial registration for a randomized, placebo-controlled study evaluating whether a single dose of intravenous ferric derisomaltose improves exercise capacity (peak VO2) in patients with heart failure with preserved ejection fraction and functional iron deficiency. No results are yet posted in this registry record; the trial is active but not recruiting.
Phase 4, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Iron-deficiency, Heart Failure With Preserved Ejection Fraction; age from 18 Years. Intervention: Arm 1. Compared with: Arm 2 — Placebo Comparator. n = 65. 1 site: United States.
This is a Phase 4 clinical trial registration for a randomized, placebo-controlled study evaluating whether a single dose of intravenous ferric derisomaltose improves exercise capacity (peak VO2) in patients with heart failure with preserved ejection fraction and functional iron deficiency. No results are yet posted in this registry record; the trial is active but not recruiting.
Primary endpoint is peak VO2, a functional surrogate; hard clinical outcomes (hospitalization, mortality) not specified.
No clinical impact can be assessed from a registry record with no posted results. Clinicians should monitor for publication of outcomes to evaluate whether intravenous iron repletion improves exercise tolerance in HFpEF patients.
This is a Phase 4 registry record with planned enrollment of 65 participants and no reported results; it describes an active interventional trial measuring peak VO2 as a surrogate endpoint, but outcomes have not yet been posted.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed from a registry record with no posted results. Clinicians should monitor for publication of outcomes to evaluate whether intravenous iron repletion improves exercise tolerance in HFpEF patients.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04945707). This is a study registration, not published results. Lead sponsor: Massachusetts General Hospital. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 65 participants (ACTUAL). Conditions: Iron-deficiency, Heart Failure With Preserved Ejection Fraction. Interventions: DRUG: Ferric Derisomaltose 1000 Mg in 100 mL INTRAVENOUS SOLUTION [Monoferric]; DRUG: Placebo. Primary outcome measures: 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. , 12 weeks. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.