RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

IRONICA: IRON Repletion in Congestive Heart Failure - A Randomized Controlled Trial Comparing Oral Versus IV Approaches

Quick Facts

Study Start:2025-04-02
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07053475

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years
  2. * BMI ≥18.0 kg/m²
  3. * Hemoglobin:
  4. * Diagnosed with Congestive Heart failure:
  5. * Documented elevated NT-proBNP based on BMI and rhythm:
  6. * NYHA Class II-IV
  7. * Transferrin saturation (TSAT) \<20%
  8. * Hemoglobin \<14 g/dL for men, \< 13 g/dL for women.
  9. * Stable on heart failure therapy for ≥2-4 weeks
  10. * Currently prescribed a diuretic at home
  11. * Ambulatory (able to walk \>20 ft with minimal assistance)
  12. * Willing and able to give informed consent
  1. * Received IV iron, ESA, or blood transfusion within the last 6-12 months
  2. * Received high-dose oral iron (\>100 mg/day in past 7 days)
  3. * Severe renal impairment (eGFR \<15 mL/min/1.73 m² or on dialysis)
  4. * Patients with known cirrhosis or transaminitis with AST \>141 or ALT \>112 IU/L
  5. * Active bleeding or known bleeding disorder
  6. * Recent cardiac surgery, myocardial infarction, or stroke within past 3 months
  7. * Active infection, defined as any systemic or deep-seated infection (e.g., bacteremia, sepsis, osteomyelitis, or infections requiring IV antibiotics or hospitalization) at the time of screening.
  8. * Active malignancy or undergoing chemotherapy/radiotherapy
  9. * Vitamin B12 or folate deficiency (unless corrected prior to enrollment)
  10. * Chronic liver disease (with LFTs \>3× upper limit of normal)
  11. * Pregnant or breastfeeding women or those not using effective contraception
  12. * Lacks capacity to consent or unable to comply with study procedures

Contacts and Locations

Study Contact

Syed H Mufarrih, MD
CONTACT
304-598-4218
hamzamufarrih@live.com
Melinda Joyce
CONTACT
(270) 535-6879
JoycMC@MCHealth.net

Study Locations (Sites)

The Medical Center
Bowling Green, Kentucky, 42101
United States

Collaborators and Investigators

Sponsor: Syed Hamza Mufarrih

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-02
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2025-04-02
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • Intravenous iron
  • Oral iron
  • Ferric carboxymaltose
  • Ferrous sulfate
  • Transferrin saturation (TSAT)
  • Functional iron deficiency
  • 6-minute walk test (6MWT)
  • Kansas City Cardiomyopathy Questionnaire (KCCQ)
  • Quality of life
  • Randomized controlled trial
  • Congestive heart failure
  • HFpEF
  • HFrEF

Additional Relevant MeSH Terms

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