RecruitingPhase 4NCT04945707

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

A Double-blind,Randomized, Placebo-controlled Study to Assess Exercise Tolerance After Iron Repletion With Ferric Derisomaltose (Monoferric®) IV Compared to Placebo in Heart Failure With Preserved Ejection Fraction and With Iron Deficiency.


Sponsor

Massachusetts General Hospital

Enrollment

66 participants

Start Date

Nov 26, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether giving intravenous (IV) iron to people with heart failure (specifically a type called HFpEF, where the heart pumps normally but is too stiff) improves their ability to exercise. Many heart failure patients are iron-deficient even without anemia, and this trial tests whether correcting that deficiency helps the heart and muscles work better. **You may be eligible if...** - You are 18 or older with stable heart failure (HFpEF — preserved ejection fraction) - Your heart's pumping function is 50% or above - You are iron-deficient (low ferritin or ferritin with low iron saturation) - You have reduced exercise capacity confirmed by a breathing test (peak VO2 ≤75% predicted) - Your hemoglobin is between 9.0 and 15.0 g/dL **You may NOT be eligible if...** - You are currently receiving or planning IV iron therapy - You have a known allergy to the iron product (ferric derisomaltose) - You have had a heart attack, stroke, or TIA in the last 3 months - You have severe kidney problems (eGFR below 20) - You have serious liver disease - You have active internal bleeding - You have another cause of anemia unrelated to iron deficiency or chronic disease - You have severe obesity (BMI over 50) or another condition that prevents safe exercise testing - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFerric Derisomaltose 1000 Mg in 100 mL INTRAVENOUS SOLUTION [Monoferric]

Ferric derisomaltose (Monoferric) 1000 mg X1 (for subject \<50 kg, 20 mg/kg

DRUGPlacebo

Normal saline


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT04945707


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