IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches
NCT ID: NCT07053475
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
250 participants
INTERVENTIONAL
2025-04-02
2027-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
Ferric Carboxymaltose
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 Iron (Ferrous Sulfate)
Patients randomized to receive one capsule of oral ferrous sulfate (Ferrex 150 mg) every 48 hours for 12 weeks.
Ferrous Sulfate
Oral administration of one 150 mg capsule every 48 hours for 12 weeks.
Interventions
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Ferric Carboxymaltose
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
Oral administration of one 150 mg capsule every 48 hours for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI ≥18.0 kg/m²
* Hemoglobin:
\> 9 g/dL and \<14 g/dL for men \> 9 g/dL and \<13 g/dL for women
* Diagnosed with Congestive Heart failure:
HFrEF: EF ≤40% in any recent echocardiogram HFpEF: EF ≥50-55% without any prior EF ≤40%, and evidence of diastolic dysfunction per ASE/EACVI 2023 criteria-defined as either grade ≥2 or ≥2 supporting echo parameters (septal e' \<7 cm/sec or lateral e' \<10 cm/sec, E/e' ≥15, TR velocity \>2.8 m/s, LA volume index ≥34 mL/m², LV septal or posterior wall thickness ≥1.2 cm, or LA area ≥20 cm² / diameter ≥3.8 cm.
* Documented elevated NT-proBNP based on BMI and rhythm:
BMI \<35: ≥220 pg/mL (NSR) or ≥660 pg/mL (A-Fib) BMI ≥35: ≥125 pg/mL (NSR) or ≥375 pg/mL (A-Fib)
* NYHA Class II-IV
* Transferrin saturation (TSAT) \<20%
* Hemoglobin \<14 g/dL for men, \< 13 g/dL for women.
* Stable on heart failure therapy for ≥2-4 weeks
* Currently prescribed a diuretic at home
* Ambulatory (able to walk \>20 ft with minimal assistance)
* Willing and able to give informed consent
Exclusion Criteria
* 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
* Active bleeding or known bleeding disorder
* Recent cardiac surgery, myocardial infarction, or stroke within past 3 months
* 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.
* Active malignancy or undergoing chemotherapy/radiotherapy
* Vitamin B12 or folate deficiency (unless corrected prior to enrollment)
* Chronic liver disease (with LFTs \>3× upper limit of normal)
* Pregnant or breastfeeding women or those not using effective contraception
* Lacks capacity to consent or unable to comply with study procedures
18 Years
100 Years
ALL
No
Sponsors
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American Regent, Inc.
INDUSTRY
Syed Hamza Mufarrih
OTHER
Responsible Party
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Syed Hamza Mufarrih
Principal Investigator
Locations
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The Medical Center
Bowling Green, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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References
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von Haehling S, Doehner W, Evertz R, Garfias-Veitl T, Derad C, Diek M, Karakas M, Birkemeyer R, Fillippatos G, Lainscak M, Butler J, Ponikowski P, Bohm M, Friede T, Anker SD. Ferric carboxymaltose and exercise capacity in heart failure with preserved ejection fraction and iron deficiency: the FAIR-HFpEF trial. Eur Heart J. 2024 Oct 5;45(37):3789-3800. doi: 10.1093/eurheartj/ehae479.
Alcaide-Aldeano A, Garay A, Alcoberro L, Jimenez-Marrero S, Yun S, Tajes M, Garcia-Romero E, Diez-Lopez C, Gonzalez-Costello J, Mateus-Porta G, Cainzos-Achirica M, Enjuanes C, Comin-Colet J, Moliner P. Iron Deficiency: Impact on Functional Capacity and Quality of Life in Heart Failure with Preserved Ejection Fraction. J Clin Med. 2020 Apr 22;9(4):1199. doi: 10.3390/jcm9041199.
Bekfani T, Pellicori P, Morris D, Ebner N, Valentova M, Sandek A, Doehner W, Cleland JG, Lainscak M, Schulze PC, Anker SD, von Haehling S. Iron deficiency in patients with heart failure with preserved ejection fraction and its association with reduced exercise capacity, muscle strength and quality of life. Clin Res Cardiol. 2019 Feb;108(2):203-211. doi: 10.1007/s00392-018-1344-x. Epub 2018 Jul 26.
Cleland JGF, Pellicori P, Graham FJ, Lane R, Petrie MC, Ahmed F, Squire IB, Ludman A, Japp A, Al-Mohammad A, Clark AL, Szwejkowski B, Critoph C, Chong V, Schiff R, Nageh T, Glover J, McMurray JJV, Thomson EA, Robertson M, Ford I, Kalra PA, Kalra PR; IRONMAN Study Group. Adjudication of Hospitalizations and Deaths in the IRONMAN Trial of Intravenous Iron for Heart Failure. J Am Coll Cardiol. 2024 Oct 29;84(18):1704-1717. doi: 10.1016/j.jacc.2024.08.052.
Manceau H, Ausseil J, Masson D, Feugeas JP, Sablonniere B, Guieu R, Puy H, Peoc'h K. Neglected Comorbidity of Chronic Heart Failure: Iron Deficiency. Nutrients. 2022 Aug 5;14(15):3214. doi: 10.3390/nu14153214.
Zhou X, Xu W, Xu Y, Qian Z. Iron Supplementation Improves Cardiovascular Outcomes in Patients with Heart Failure. Am J Med. 2019 Aug;132(8):955-963. doi: 10.1016/j.amjmed.2019.02.018. Epub 2019 Mar 7.
Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
Other Identifiers
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AR2059
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
24-11-18-Mufa-OralvsIV-Iron
Identifier Type: -
Identifier Source: org_study_id
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