IV Iron Replacement for Heart Failure

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Radha Gopalan

Must be taking: Intravenous iron

Disqualifiers: Iron overload, Recent ACS, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how iron infusions can assist people with heart failure and low iron levels. The main goal is to determine if increased iron improves participants' exercise capacity. Participants will be divided into two groups: one will receive iron infusions intravenously, and the other will not. This trial may suit individuals with heart failure, noticeable symptoms, and lower iron levels. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, providing participants an opportunity to benefit from established therapies while contributing to broader understanding.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for IV iron infusion?

Studies have shown that receiving iron through an IV can be safe for people with heart failure who also lack sufficient iron. Research involving over 7,000 patients suggests that IV iron can help reduce the risk of heart failure complications and heart-related issues. However, some studies on healthy individuals found that IV iron might cause temporary changes in blood vessels and increase stress markers in the body.

Overall, patients who need IV iron infusion seem to tolerate it well. Specifically, it has been shown to lower the risk of hospital visits or deaths related to heart failure by up to 21%. While these findings are promising, discussing any possible side effects or concerns with a healthcare provider is important before considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for heart failure, which typically involve medications like beta-blockers, ACE inhibitors, or diuretics to manage symptoms and improve heart function, the IV Iron Infusion treatment is unique because it directly targets iron deficiency. Researchers are excited about this treatment because it uses intravenous iron to quickly replenish iron levels in the body, potentially improving energy levels and exercise capacity in heart failure patients. This direct method of delivery allows for rapid absorption and may offer benefits in just a week, which is faster than many oral supplements.

What evidence suggests that IV iron infusion might be an effective treatment for heart failure?

Research has shown that giving iron directly into the bloodstream (IV iron infusion) can help people with heart failure who also have low iron levels. In this trial, participants in the IV Iron Infusion Group will receive this treatment. Studies indicate that IV iron can reduce the risk of hospitalization for heart failure by about 25%. It also improves exercise ability, often measured by how much oxygen the body can use during intense activities. A review of research involving over 7,000 patients found that IV iron lowers the chance of repeated heart failure problems. While some studies suggest it doesn't change death rates, the benefits for heart function and exercise ability are clear. Overall, IV iron infusion is a proven treatment for heart failure patients with low iron levels. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 with heart failure who have iron deficiency (ferritin <100 ng/mL or ferritin 100-300 ng/mL with TSAT <20%) and reduced heart function (ejection fraction ≤40%). They should be able to exercise and follow the study plan. Excluded are those with severe heart failure, active bleeding, recent heart issues, pregnancy, short life expectancy, certain deficiencies or allergies.

Inclusion Criteria

I have moderate heart failure.

The patient is willing and able to comply with the protocol and has provided written informed consent

Your ferritin levels are less than 100 ng/mL or between 100-300 ng/mL with low transferrin saturation.

Exclusion Criteria

I do not have iron overload, allergies to it, or lack of B12 and folate.

I recently had a heart attack or related condition.

My heart condition severely limits my physical activity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IV iron infusion or are assigned to the control group

2 months

1 visit (in-person) for iron infusion, additional visits as needed

Follow-up

Participants are monitored for exercise capacity and quality of life improvements

2 months

2 visits (in-person) for exercise testing and questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• IV Iron Infusion Group

Trial Overview

The trial is testing if IV iron infusions can improve exercise capacity in patients with a specific type of heart failure and iron deficiency. Participants will either receive the iron infusion or be placed in a control group without it. The main measure of success is an increase in peak oxygen uptake during exercise.

How Is the Trial Designed?

Group I: IV Iron Infusion Group Experimental Treatment 1 Intervention

Subjects will receive iron infusion 1 week after enrollment. Dosage of iron will be at discretion of physicians

Group II: Control Group Active Control 1 Intervention

Subjects will not receive iron replacement infusion.

Who Is Running the Clinical Trial?

Radha Gopalan

Lead Sponsor

Trials

1

Recruited

40+

American Regent, Inc.

Industry Sponsor

Trials

62

Recruited

19,300+

Paul Diolosa

American Regent, Inc.

Chief Executive Officer since 2021

BS in Mechanical Engineering from Virginia Polytechnic Institute and State University, MBA from New York Dowling College

Emily Huynh

American Regent, Inc.

Chief Medical Officer since 2022

PharmD

Published Research Related to This Trial

In a study of 172 patients with acute heart failure, those who received intravenous (IV) iron therapy showed a significant increase in hemoglobin levels compared to those who did not, with changes of 2.61 g/dl versus 0.23 g/dl by day 28.

The administration of IV iron was well tolerated, and while the 30-day readmission rates were 30% for the IV iron group and 22% for the control group, this difference was not statistically significant, suggesting that IV iron therapy does not increase readmission risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Total Dose Infusion of Iron Intravenously in Patients With Acute Heart Failure and Anemia (Hemoglobin Kaminsky, BM., Pogue, KT., Hanigan, S., et al.[2018]

Citations

1.

nature.com

nature.com/articles/s41591-025-03671-1

Systematic review and meta-analysis of intravenous iron ...

This meta-analysis, comprising >7,000 patients, suggests that i.v. iron reduces the composite endpoint of total (first and recurrent) HF ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40810693/

Intravenous Iron in Heart Failure Patients With Iron Deficiency

For HF patients with ID, intravenous iron therapy can decrease the risk of hospitalization for HF, CV death and improve their exercise ...

3.

journal-of-cardiology.com

journal-of-cardiology.com/article/S0914-5087(23)00157-0/fulltext

Clinical outcomes of intravenous iron therapy in patients ...

IV iron leads to a significant reduction in heart failure hospitalization by 25 %. •. No significant difference in cardiac or mortality, GI ...

4.

acc.org

acc.org/Latest-in-Cardiology/Clinical-Trials/2022/11/04/14/19/ironman

Effectiveness of Intravenous Iron Treatment Versus ...

The results of this trial show that iron infusion is not superior to usual care among patients with HF and iron deficiency. No changes in ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41080322/

A Network Meta-Analysis of Randomized Controlled Trials

IV iron significantly improved 6MWD compared to placebo (mean difference (MD) +26.0 m; 95% confidence interval (CI): 18.1 to 33.9), increased ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40159279/

Systematic review and meta-analysis of intravenous iron ...

These findings suggest that treating iron deficiency in patients with HF significantly reduces cardiovascular events and suggests further investigation of ...

7.

ahajournals.org

ahajournals.org/doi/10.1161/circulationaha.121.054271

Intravenous Iron Therapy in Heart Failure With Reduced ...

In healthy human volunteers, intravenous iron resulted in transient endothelial dysfunction and biomarkers of oxidative stress.

8.

acc.org

acc.org/About-ACC/Press-Releases/2025/03/30/12/35/Intravenous-Iron-Offers-Some-Benefits-for-Some-Patients-with-Heart-Failure

Intravenous Iron Offers Some Benefits for Some Patients ...

According to the results, patients in the treatment group had a 21% lower risk of cardiovascular death or first heart failure hospitalization ...