Heart FailureNCT07277140
Impact of Iron Deficiency on Arrhythmic Events and Resting ECG Abnormalities in Patients Hospitalized With Heart Failure
An observational study of Heart Failure and Iron Deficiency, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Iron Deficiency
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) admitted with heart failure over a period of one year at Assiut University Heart Hospital (AUHH)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Conditions
- Heart Failure, Iron Deficiency
- Medical subject headings
- Heart Failure, Iron Deficiencies
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%).
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Resting ECG abnormalities in hospitalized HF patients with and without iron deficiency
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%).
Measured: through study completion, an average of 1 year
Correlation between iron parameters, anemia status, and resting electrophysiologic parameters on 12-lead ECG
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
Measured: through study completion, an average of 1 year
Association between iron parameters (and anemia) and electrophysiologic parameters
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Mohamed Sadek, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277140
- Sponsor's protocol ID
- Iron deficiency& Heart failure
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
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 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.
PubMed 27324686Salah 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.
PubMed 35919090Boulet 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.
PubMed 38546848McDonagh 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.
PubMed 30311713Pantopoulos 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.
PubMed 22703180Hindricks 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.
PubMed 34520521Chung 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.
PubMed 30779710
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Iron Deficiency With and Without Anemia on Arrhythmic Events and Resting ECG Abnormalities in Patients Hospitalized With Heart Failure
- ClinicalTrials.gov ID
- NCT07277140
- Acronym / sponsor ID
- Iron deficiency& Heart failure
- Conditions
- Heart Failure, Iron Deficiency
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) admitted with heart failure over a period of one year at Assiut University Heart Hospital (AUHH)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%.
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%).
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Results publication: PubMed 27324686Crespo-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.
- Results publication: PubMed 35919090Salah 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.
- Results publication: PubMed 38546848Boulet 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.
- Results publication: PubMed 30311713McDonagh 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.
- Results publication: PubMed 22703180Pantopoulos 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.
- Results publication: PubMed 34520521Hindricks 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.
- Results publication: PubMed 30779710Chung 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.
- Individual participant dataSharing planned: Yes
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Iron Deficiency, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samar Mohamed Sadek, Master degree (+201055045413, Samar.17289550@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of anemia and iron deficiency in hospitalized patients with HF (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07277140, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.