The goal of this clinical trial is to learn which iron treatment works better for adults with congestive heart failure and low iron levels: intravenous (IV) iron given through a vein or oral (PO) iron taken by mouth. Participants must have heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) and a transferrin-saturation (TSAT) level below 20 percent.
The main questions the study will answer are:
1. Does IV iron raise walking distance on a 6-minute walk test more than oral iron after 24 weeks? 2. Does IV iron improve symptoms and quality of life more than oral iron? 3. How do the two treatments compare for safety, side effects, and hospital readmissions/ mortality?
Researchers will compare IV ferric carboxymaltose with oral ferrous sulfate to see which option helps people feel and function better.
What participants will do
* Be randomly assigned by (like flipping a coin) to IV iron or oral iron. * Receive either a one-time IV iron infusion (with possible repeat at 12 weeks) or take iron pills twice each day for 24 weeks. * Visit the infusion clinic at 6 weeks for second dose of IV iron if needed. * Visit the clinic at 12 weeks for a follow-up to gather follow-up data including
1. A 6-minute walk test 2. Brief symptom and quality-of-life surveys 3. Blood tests to measure serum iron, ferritin, and transferrin saturation
This study will help doctors decide whether IV or oral iron is the safer, more effective way to treat iron deficiency in people with heart failure in our local community.
Age ≥18 years
BMI ≥18.0 kg/m²
NYHA Class II-IV
Transferrin saturation (TSAT) <20%
Received IV iron, ESA, or blood transfusion within the last 6-12 months
Received high-dose oral iron (>100 mg/day in past 7 days)
Severe renal impairment (eGFR <15 mL/min/1.73 m² or on dialysis)
Patients with known cirrhosis or transaminitis with AST >141 or ALT >112 IU/L
Parallel
Ferric Carboxymaltose
DrugIntravenous infusion of 1 gram FCM during index hospital stay, followed by a second dose at Week 6 (1,000 mg if \> 70 kg or 500 mg if ≤ 70 kg).
Ferrous Sulfate
DrugOral administration of one 150 mg capsule every 48 hours for 12 weeks.
Change in 6-Minute Walk Distance
Change in distance (in meters) walked during the 6-minute walk test from baseline to 12 weeks.
Change in NYHA Functional Class
Change in New York Heart Association (NYHA) class from baseline to 12 weeks.
Change in Quality of Life
Change in patient-reported quality of life scores as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Change in Iron Stores
Change in iron parameters including serum ferritin, serum iron, and transferrin saturation from baseline to 12 weeks.
All-Cause Mortality
Death from any cause during the 12-week study period.
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Syed Hamza Mufarrih
Lead sponsor
Western Kentucky Heart and Lung Research Foundation and Educational Trust
Sponsor institution
American Regent, Inc.
Collaborator
