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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
Intravenous 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).
Oral administration of one 150 mg capsule every 48 hours for 12 weeks.
The Medical Center
Bowling Green, Kentucky, United States
RECRUITINGChange in 6-Minute Walk Distance
Change in distance (in meters) walked during the 6-minute walk test from baseline to 12 weeks.
Time frame: Baseline and 12 weeks
Change in NYHA Functional Class
Change in New York Heart Association (NYHA) class from baseline to 12 weeks.
Time frame: Baseline and 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)
Time frame: Baseline and 12 weeks
Change in Iron Stores
Change in iron parameters including serum ferritin, serum iron, and transferrin saturation from baseline to 12 weeks.
Time frame: Baseline and 12 weeks
All-Cause Mortality
Death from any cause during the 12-week study period.
Time frame: Through 12 weeks
Heart Failure Readmissions
Number of heart failure-related hospital readmissions within 12 weeks.
Time frame: Through 12 weeks
Major Adverse Cardiac Events (MACE)
Composite of cardiovascular death, myocardial infarction, or stroke during the 12-week study period.
Time frame: Through 12 weeks
Adverse Events Related to Study Drug
Frequency of reported adverse effects attributed to either ferric carboxymaltose or oral ferrous sulfate during the study period.
Time frame: Through 12 weeks
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