Impact of Iron Deficiency on Arrhythmic Events and Resting ECG Abnormalities in Patients Hospitalized With Heart Failure

NCT07277140 | Not Yet Recruiting DMC

• 1 other identifier: Iron deficiency& Heart failure
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The relationship between iron deficiency (with or without anemia) and arrhythmic risk or ECG abnormalities in hospitalized HF patients remains poorly characterized. This is particularly relevant in settings where advanced iron therapies (e.g., intravenous iron supplementation) may not be readily available, and where simple clinical and electrocardiographic markers could help identify high-risk patients by evaluating the impact of iron deficiency (with and without anemia) arrhythmic events and resting ECG changes among patients admitted with heart failure. Understanding these associations may offer insights into the arrhythmogenic potential of iron deficiency and support the integration of iron status assessment into routine risk stratification and management of HF patients.

Conditions

Iron Deficiency; Heart Failure

Outcome Measures

Primary Outcomes (2)

• Incidence of anemia and iron deficiency in hospitalized patients with HF

  The proportion of patients admitted with heart failure who are found to have anemia and/or iron deficiency during hospitalization. Anemia is defined according to WHO criteria (Hb \<13 g/dL in men, \<12 g/dL in women). Iron deficiency is defined as ferritin \<100 ng/mL, or ferritin 100-299 ng/mL with transferrin saturation \<20%.

  through study completion, an average of 1 year

• Incidence of arrhythmic events in hospitalized HF patients with and without iron deficiency possible

  The proportion of hospitalized heart failure patients who experience arrhythmic events (such as atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or clinically significant bradyarrhythmias) during admission. Patients will be categorized based on the presence or absence of iron deficiency (defined by ferritin \<100 ng/mL, or ferritin 100-299 ng/mL with transferrin saturation \<20%).

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Resting ECG abnormalities in hospitalized HF patients with and without iron deficiency

  through study completion, an average of 1 year

• Correlation between iron parameters, anemia status, and resting electrophysiologic parameters on 12-lead ECG

  through study completion, an average of 1 year

• Association between iron parameters (and anemia) and electrophysiologic parameters

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) admitted with heart failure over a period of one year at Assiut University Heart Hospital (AUHH)

You may qualify if:

• Adult patients (≥18 years) admitted to Assiut University Heart Hospital with a clinical diagnosis of heart failure (new-onset or decompensated).
• Includes all ejection fraction categories (HFrEF, HFmrEF, and HFpEF).
• Availability of 12-lead ECG, serum iron studies (ferritin, transferrin saturation, serum iron), and routine laboratory tests.
• Willingness to participate and provide informed consent.

You may not qualify if:

• Known history of primary electrical disorders (e.g., Brugada syndrome, Long QT syndrome, etc.).
• Recent intravenous iron therapy or blood transfusion within the past 3 months.
• End-stage renal disease requiring dialysis.
• Known anemia due to non-iron-deficiency causes (e.g., hemolytic anemia, active malignancy, etc.).
• Severe electrolyte imbalances (e.g., significant hypo-/hyperkalemia, hypo-/hypermagnesemia).
• Active systemic infection, chronic inflammatory conditions, or recent chemotherapy.
• severe valvular lesions

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Crespo-Leiro MG, Anker SD, Maggioni AP, Coats AJ, Filippatos G, Ruschitzka F, Ferrari R, Piepoli MF, Delgado Jimenez JF, Metra M, Fonseca C, Hradec J, Amir O, Logeart D, Dahlstrom U, Merkely B, Drozdz J, Goncalvesova E, Hassanein M, Chioncel O, Lainscak M, Seferovic PM, Tousoulis D, Kavoliuniene A, Fruhwald F, Fazlibegovic E, Temizhan A, Gatzov P, Erglis A, Laroche C, Mebazaa A; Heart Failure Association (HFA) of the European Society of Cardiology (ESC). European Society of Cardiology Heart Failure Long-Term Registry (ESC-HF-LT): 1-year follow-up outcomes and differences across regions. Eur J Heart Fail. 2016 Jun;18(6):613-25. doi: 10.1002/ejhf.566.

  PMID: 27324686 RESULT

• Salah HM, Minhas AMK, Khan MS, Pandey A, Michos ED, Mentz RJ, Fudim M. Causes of hospitalization in the USA between 2005 and 2018. Eur Heart J Open. 2021 Jun 15;1(1):oeab001. doi: 10.1093/ehjopen/oeab001. eCollection 2021 Aug.

  PMID: 35919090 RESULT

• Boulet J, Sridhar VS, Bouabdallaoui N, Tardif JC, White M. Inflammation in heart failure: pathophysiology and therapeutic strategies. Inflamm Res. 2024 May;73(5):709-723. doi: 10.1007/s00011-023-01845-6. Epub 2024 Mar 28.

  PMID: 38546848 RESULT

• McDonagh T, Damy T, Doehner W, Lam CSP, Sindone A, van der Meer P, Cohen-Solal A, Kindermann I, Manito N, Pfister O, Pohjantahti-Maaroos H, Taylor J, Comin-Colet J. Screening, diagnosis and treatment of iron deficiency in chronic heart failure: putting the 2016 European Society of Cardiology heart failure guidelines into clinical practice. Eur J Heart Fail. 2018 Dec;20(12):1664-1672. doi: 10.1002/ejhf.1305. Epub 2018 Oct 12.

  PMID: 30311713 RESULT

• Pantopoulos K, Porwal SK, Tartakoff A, Devireddy L. Mechanisms of mammalian iron homeostasis. Biochemistry. 2012 Jul 24;51(29):5705-24. doi: 10.1021/bi300752r. Epub 2012 Jul 9.

  PMID: 22703180 RESULT

• Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL. Corrigendum to: 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Oct 21;42(40):4194. doi: 10.1093/eurheartj/ehab648. No abstract available.

  PMID: 34520521 RESULT

• Chung YJ, Luo A, Park KC, Loonat AA, Lakhal-Littleton S, Robbins PA, Swietach P. Iron-deficiency anemia reduces cardiac contraction by downregulating RyR2 channels and suppressing SERCA pump activity. JCI Insight. 2019 Apr 4;4(7):e125618. doi: 10.1172/jci.insight.125618. eCollection 2019 Apr 4.

  PMID: 30779710 RESULT

MeSH Terms

Conditions

Heart Failure; Iron Deficiencies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Samar Mohamed Sadek, Master degree

CONTACT

+201055045413; Samar.17289550@med.aun.edu.eg

Mohamed Abo Elhassan, Doctorate

CONTACT

+201115825387; mabolhassan10@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Resident, Principal Investigator

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: December 11, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share