IV Iron Replacement for Heart Failure

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Radha Gopalan

No Placebo Group

Prior Safety Data

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.

Research Team

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

I am between 18 and 90 years old.

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

I have moderate heart failure.

See 3 more

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.

See 7 more

Treatment Details

Interventions

IV Iron Infusion Group (Iron Replacement)

Trial OverviewThe 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

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.