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Not yet recruiting NCT07277140

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

Observational Heart Failure Iron Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Heart Failure, Iron Deficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Iron Deficiency With and Without Anemia on Arrhythmic Events and Resting ECG Abnormalities in Patients Hospitalized With Heart Failure

Overview

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

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

Primary outcome measures

  • Incidence of anemia and iron deficiency in hospitalized patients with HF [Time frame: through study completion, an average of 1 year]
  • Incidence of arrhythmic events in hospitalized HF patients with and without iron deficiency possible [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (3)
  • Resting ECG abnormalities in hospitalized HF patients with and without iron deficiency [Time frame: through study completion, an average of 1 year]
  • Correlation between iron parameters, anemia status, and resting electrophysiologic parameters on 12-lead ECG [Time frame: through study completion, an average of 1 year]
  • Association between iron parameters (and anemia) and electrophysiologic parameters [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 Asso PMID 27324686
  • 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
  • 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
  • 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/ PMID 30311713
  • 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
  • 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 collaborati PMID 34520521
  • 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

Identifiers

NCT: NCT07277140 · Iron deficiency& Heart failure

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗