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Iron Replacement

IV Iron Replacement for Heart Failure

Phase 4
Waitlist Available
Research Sponsored by Radha Gopalan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-90 years
New York Heart Association Class II-III heart failure
Must not have
Recent Acute Coronary Syndrome
NYHA class IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months after iv iron infusion
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial investigates how iron replacement can improve exercise capacity in heart failure patients with iron deficiency.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from IV iron infusions include allergic reactions, low blood pressure during infusion, muscle cramps, nausea, joint pain, dizziness or fainting. However not everyone experiences these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 90 years old.
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I have moderate heart failure.
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My heart's left ventricle is not pumping well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I recently had a heart attack or related condition.
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My heart condition severely limits my physical activity.
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I am currently experiencing a worsening of my heart failure.
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I am currently experiencing active bleeding.
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I have a long-term liver condition.
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I have chosen not to participate in this trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months after iv iron infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months after iv iron infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Exercise Capacity
Patient subjective outcome measures
Secondary study objectives
Objective Quality of Life measures

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IV Iron Infusion GroupExperimental Treatment1 Intervention
Subjects will receive iron infusion 1 week after enrollment. Dosage of iron will be at discretion of physicians
Group II: Control GroupActive Control1 Intervention
Subjects will not receive iron replacement infusion.

Find a Location

Who is running the clinical trial?

Radha GopalanLead Sponsor
American Regent, Inc.Industry Sponsor
61 Previous Clinical Trials
19,395 Total Patients Enrolled
1 Trials studying Heart Failure
3,065 Patients Enrolled for Heart Failure

Media Library

IV Iron Infusion Group (Iron Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT05816265 — Phase 4
Heart Failure Research Study Groups: IV Iron Infusion Group, Control Group
Heart Failure Clinical Trial 2023: IV Iron Infusion Group Highlights & Side Effects. Trial Name: NCT05816265 — Phase 4
IV Iron Infusion Group (Iron Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05816265 — Phase 4
~21 spots leftby Mar 2026
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