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

December 10, 2025 updated by: Samar Mohamed Sadek, Assiut University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of anemia and iron deficiency in hospitalized patients with HF
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resting ECG abnormalities in hospitalized HF patients with and without iron deficiency
Time Frame: through study completion, an average of 1 year
The prevalence and types of resting ECG abnormalities (e.g., atrial fibrillation/flutter, QRS prolongation >120 ms, ST-T changes, pathological Q waves, left ventricular hypertrophy, bundle branch blocks, premature ventricular complexes) in hospitalized heart failure patients. Patients will be stratified according to the presence or absence of iron deficiency (defined as ferritin <100 ng/mL, or ferritin 100-299 ng/mL with transferrin saturation <20%).
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

This outcome evaluates the correlation between iron status indicators (serum ferritin, transferrin saturation, and serum iron levels) and anemia-defined according to WHO criteria (hemoglobin <13 g/dL in men, <12 g/dL in women)-with resting electrophysiologic parameters obtained from a standard 12-lead ECG.

Each electrophysiologic parameter will be correlated separately with continuous iron and hemoglobin values
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

Assessment of the relationship between iron status (ferritin, transferrin saturation, serum iron) and anemia (defined by WHO criteria: Hb <13 g/dL in men, <12 g/dL in women) with resting electrophysiologic parameters on 12-lead ECG. Parameters include:

Rhythm: sinus rhythm, atrial fibrillation/flutter, ventricular arrhythmias

Conduction: PR interval, QRS duration, bundle branch block

Repolarization: QT/QTc interval, ST-T abnormalities

Heart rate variability (if available)

Patients will be stratified according to presence/absence of iron deficiency and anemia, and correlations will be examined between continuous iron parameters and ECG metrics.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Iron deficiency& Heart failure

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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