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

NCT ID: NCT07277140

Last Updated: 2025-12-11

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-15

Study Completion Date

2027-10-01

Brief Summary

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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.

Detailed Description

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Heart failure (HF) is a major global health problem, associated with high morbidity, mortality, and frequent hospitalizations. Beyond impaired cardiac function, HF is recognized as a systemic syndrome involving a wide range of metabolic, inflammatory, and hematologic disturbances that contribute to disease progression and adverse outcomes. Iron deficiency has emerged as a prevalent and clinically relevant comorbidity, affecting up to 55% of chronic HF patients and in up to 80% of those with AHF, even in the absence of overt anemia.

Iron plays a central role in cellular energy metabolism, oxidative phosphorylation, and mitochondrial function, processes that are especially critical in the metabolically demanding environment of the myocardium.

In patients with HF, anemia and iron deficiency has been associated with reduced exercise capacity, impaired quality of life, and increased risk of hospitalization, cardiovascular and all-cause mortality. While the impact of iron deficiency on functional status and survival has been widely investigated, its potential influence on cardiac electrical activity remains less well studied.

Emerging evidence suggests that iron deficiency may contribute to electrophysiological instability by promoting oxidative stress, altering repolarization, and impairing myocardial conduction. This could create a potential substrate for arrhythmias, which are a major cause of morbidity in patients with HF. Moreover, subtle resting electrocardiographic (ECG) abnormalities, such as QT prolongation, T-wave changes, or conduction delays, may reflect early electrical remodeling in the context of iron deficiency-even in the absence of clinically apparent arrhythmias

Conditions

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Heart Failure Iron Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Samar Mohamed Sadek

Cardiology Resident, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Samar Mohamed Sadek, Master degree

Role: CONTACT

+201055045413

Mohamed Abo Elhassan, Doctorate

Role: CONTACT

+201115825387

References

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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.

Reference Type RESULT
PMID: 27324686 (View on PubMed)

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.

Reference Type RESULT
PMID: 35919090 (View on PubMed)

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.

Reference Type RESULT
PMID: 38546848 (View on PubMed)

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.

Reference Type RESULT
PMID: 30311713 (View on PubMed)

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.

Reference Type RESULT
PMID: 22703180 (View on PubMed)

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.

Reference Type RESULT
PMID: 34520521 (View on PubMed)

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.

Reference Type RESULT
PMID: 30779710 (View on PubMed)

Other Identifiers

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Iron deficiency& Heart failure

Identifier Type: -

Identifier Source: org_study_id

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