IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches

Conditions

• Heart Failure
• Heart Failure With Preserved Ejection Fraction (HFPEF)
• Heart Failure With Reduced Ejection Fraction (HFrEF)
• Iron Deficiency
• Iron-deficiency Anemia (IDA)

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Ferric Carboxymaltose — DRUG
  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).
• Ferrous Sulfate — DRUG
  Oral administration of one 150 mg capsule every 48 hours for 12 weeks.

Study Details

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.

Key Dates

Start date

Apr 2, 2025

Status verified

Jun 2025

Primary completion

Dec 31, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: IV Iron (Ferric Carboxymaltose)
  Patients randomized to receive intravenous ferric carboxymaltose. Dosing includes a 1-gram IV infusion during the index hospital stay, followed by a second infusion at Week 6 (1,000 mg if \> 70 kg or 500 mg if ≤ 70 kg).
• Active Comparator: Oral Iron (Ferrous Sulfate)
  Patients randomized to receive one capsule of oral ferrous sulfate (Ferrex 150 mg) every 48 hours for 12 weeks.

Primary Outcome Measure

Change in 6-Minute Walk Distance [ Time Frame: Baseline and 12 weeks ]

Central Contacts

• Syed H Mufarrih, MD
  304-598-4218
  [email protected]
• Melinda Joyce
  (270) 535-6879
  [email protected]

Locations (1)

Find similar trials in Bowling Green, KY

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