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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
IRONMETHFpEF 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.Check my eligibility
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.See study design
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.
IRONMETHFpEF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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.
Secondary outcome measures
Change in C-reactive Protein
Change in NTpBNP
Change in Quality of Life
+11 moreIRONMETHFpEF Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Arm 1Active Control1 Intervention
Ferric derisomaltose (Monoferric®) 1000 mg X 1 (for subject <50 kg, 20 mg/kg X1)
Group II: Arm 2Placebo Group1 Intervention
Normal Saline
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,415 Total Patients Enrolled
48 Trials studying Heart Failure
209,559 Patients Enrolled for Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,528 Total Patients Enrolled
206 Trials studying Heart Failure
677,382 Patients Enrolled for Heart Failure
Pharmacosmos A/SIndustry Sponsor
44 Previous Clinical Trials
9,636 Total Patients Enrolled
2 Trials studying Heart Failure
1,180 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is severely impaired.You are allergic to any part of the medication ferric derisomaltose (Monofer®).You have a condition that makes it difficult to do exercise testing, like severe leg pain, uncontrolled heart rhythm problems, serious muscle or bone diseases, or very high body weight.I have not had a heart attack, stroke, or similar event in the last 3 months.I have cancer that is not a non-melanoma skin cancer.My heart failure condition has been stable for at least 4 weeks.I am 18 years or older and can give my consent.Your blood test shows low iron levels, but not extremely low.You need to do a special breathing and exercise test and reach a certain level of effort.My heart pumps well, with an ejection fraction of 50% or more.I have heart issues indicated by specific tests or a recent hospital stay for heart failure.I have a history of too much iron in my body or recently had treatments affecting my blood.My liver function tests are not severely abnormal.My anemia is not due to iron deficiency or a long-term illness.You can't do as much exercise as expected for someone your age and gender, based on a test.I am not pregnant, breastfeeding, and I agree to use birth control during and 5 days after the study.I cannot come back for follow-up visits.I am scheduled for surgery during the trial.I am currently experiencing active bleeding in my digestive tract.I am currently taking or planning to take intravenous iron supplements.Your hemoglobin level needs to be between 9.0 and 15.0 grams per deciliter.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is generally the purpose of utilizing Arm 1?
"Arm 1 of this trial involves treating iron deficiency anemia with a combination of dietary changes and supplemental doses of the trace element."
Answered by AI
Is this clinical investigation presently soliciting participants?
"Affirmative. Information available on clinicaltrials.gov displays that this medical study, published initially in late November 2021, is currently recruiting individuals. 66 participants must be enrolled from one single site."
Answered by AI
What level of security is associated with Arm 1 for participants?
"Extensive data collected from Phase 4 trials, which is the final step for a medication to receive approval, has led our team at Power to rate Arm 1's safety at 3."
Answered by AI
What is the current enrollment figure for this clinical experiment?
"Affirmative. Clinicaltrials.gov substantiates that this medical research is actively searching for participants, which was initially posted on 26th November 2021 and most recently updated on 16th August 2022. 66 volunteers are required from 1 centre of study."
Answered by AI
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