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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Patients with heart failure with reduced ejection fraction and iron deficiency will be randomized to either receive iron infusion or be in the control group. The study is looking at how iron replacement affects exercise capacity as measured by peak oxygen uptake.

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 data supports the effectiveness of the treatment IV Iron Infusion Group for heart failure?

Research shows that intravenous (IV) iron treatment in heart failure patients with iron deficiency can reduce hospitalizations, improve exercise capacity, and enhance quality of life. However, its impact on survival is still uncertain. ^{1 2 3 4 5}

Is IV iron replacement safe for humans?

IV iron therapy is generally considered safe, with studies showing no serious adverse events or severe allergic reactions. Some mild side effects like skin rash or chest pain have been reported, but they are not common. ^{4 6 7 8 9}

How does the IV iron infusion treatment for heart failure differ from other treatments?

The IV iron infusion treatment for heart failure is unique because it directly addresses iron deficiency, which is common in heart failure patients, by delivering iron intravenously (through a vein). This method has been shown to improve exercise capacity and reduce hospitalizations, although its impact on survival is still uncertain. ^{4 5 8 10 11}

Eligibility Criteria

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

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

I have moderate heart failure.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Iron Deficiency Anemia in Nigerians with Heart Failure (IDAN-HF): Therapeutic efficacy of iron replacement: An interventional study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Rationale and design of a randomised trial of intravenous iron in patients with heart failure. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Intravenous iron in patients with heart failure and iron deficiency: an updated meta-analysis. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Use of intravenous iron in patients with iron deficiency and chronic heart failure: Real-world evidence. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Iron replacement therapy in heart failure: a literature review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Comparative rates of adverse events with different formulations of intravenous iron. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Baseline characteristics of patients in the randomized study to investigate the efficacy and safety of ferric carboxymaltose as treatment for heart failure with iron deficiency: HEART-FID trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of Total Dose Infusion of Iron Intravenously in Patients With Acute Heart Failure and Anemia (Hemoglobin [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Intravenous Iron for Heart Failure: Updated Systematic Review and Meta-Analysis. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical outcomes of intravenous iron therapy in patients with heart failure and iron deficiency: Meta-analysis and trial sequential analysis of randomized clinical trials. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

IV Sodium Ferric Gluconate Complex in Patients With Iron Deficiency Hospitalized due to Acute Heart Failure-Investigator Initiated, Randomized Controlled Trial. [2022]