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Iron Supplement

Intravenous Iron for Heart Failure (IRONMETHFpEF Trial)

Phase 4

Recruiting

Led By Greg Lewis, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Severe renal dysfunction (eGFR< 20 ml/min/1.73m2)

Active malignancy other than non-melanoma skin cancers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will test if iron deficiency correction can improve heart failure with preserved ejection fraction by measuring peak oxygen uptake.

Who is the study for?

Adults with heart failure and preserved ejection fraction, stable condition, iron deficiency (specific serum ferritin and TSAT levels), reduced exercise capacity, certain NT-proBNP levels or history of heart issues. Excludes pregnant women not using contraception, recent stroke/heart attack patients, those with severe liver/renal disease, known allergies to the study drug, ongoing iron treatments/blood transfusions.

What is being tested?

The trial is testing if a single dose of intravenous iron (ferric derisomaltose) can improve exercise ability in people with heart failure who have normal heart pumping function but are low on iron. Exercise capacity will be measured by changes in peak oxygen uptake after 12 weeks compared to before treatment.

What are the potential side effects?

Potential side effects may include allergic reactions to ferric derisomaltose components, gastrointestinal upset or bleeding (if predisposed), and possibly an overload of iron for those susceptible.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is severely impaired.

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I have cancer that is not a non-melanoma skin cancer.

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My liver function tests are not severely abnormal.

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My anemia is not due to iron deficiency or a long-term illness.

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I am not pregnant, breastfeeding, and I agree to use birth control during and 5 days after the study.

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I cannot come back for follow-up visits.

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I am scheduled for surgery during the trial.

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I am currently experiencing active bleeding in my digestive tract.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

Change in C-reactive Protein

Change in NTpBNP

Change in Quality of Life

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