Effects of IV Iron Replacement on Exercise Capacity in Individuals With Heart Failure

• Status: Enrolling by invitation
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radha Gopalan
• Collaborator: American Regent, Inc.

Criteria

Inclusion Criteria:

• Age 18-90 years

• New York Heart Association Class II-III heart failure

• Left ventricular dysfunction with left ventricular ejection fraction ≤ 40%

• Ferritin < 100 ng/mL or 100-300 ng/mL with transferrin saturation (TSAT) < 20%

• Patients deemed by an attending physician to require intravenous iron therapy

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

Exclusion Criteria:

• Iron overload disorders or allergy, concomitant nutritional deficiencies- B12 and folate

• Recent Acute Coronary Syndrome

• Physical barriers to exercise capacity

• Currently presenting in heart failure exacerbation

• Declined participation

• Chronic liver disease

• NYHA class IV

• Active bleeding

• Pregnancy

• Life expectancy ≤ 12 months