Iron Deficiency in Patients With Heart Failure and Reduced Evection Fraction
Study Details
Study Description
Brief Summary
About half of patients with heart failure and reduced ejection fraction (HFrEF) have iron deficiency who are symptomatic. This is independently associated with bad quality of life, low functional capacity, lower quality of, life and increased mortality. The prevalence of iron deficiency in HFrEF patients in Jordan has not been studied in the past.
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Detailed Description
The prevalence of chronic heart failure among the industrialized countries is 1-3%, and can exceed 30% in the elderly population[1]. As the population ages, there is an increase in the number of co-morbidities among heart failure patients[2]. These comorbidities are associated with an increase in major adverse cardiac events (MACE), cost, and complexity of care[3]. Iron deficiency is one of the most common comorbidities occurring in patients with heart failure. Its prevalence can be as high as 59%, even if patients are non-anemic[4]. Iron deficiency in heart failure can lead to an impaired exercise capacity, a decreased quality of life and an increased risk of hospitalizations and mortality regardless of anemia[4]-[8]. The relationship between the severity of iron deficiency and the prognosis is a linear one, with increased severity being associated with increased mortality[6].
Intravenous iron treatment has been shown to improve the quality of life, with an increased exercise capacity and a reduced risk for hospitalizations [9]-[11]. The prevalence of iron deficiency in HFrEF patients in Middle Eastern population has not been studied. We suspect a higher prevalence compared to Western populations especially in women.
References:
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- Mcmurray et al., "ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012," European Journal of Heart Failure, vol. 14, no. 8. pp. 803-869, Aug. 2012. doi:10.1093/eurjhf/hfs105.
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- Triposkiadis et al., "Reframing the association and significance of co-morbidities in heart failure," European Journal of Heart Failure, vol. 18, no. 7. John Wiley and Sons Ltd, pp. 744-758, Jul. 01, 2016. doi: 10.1002/ejhf.600.
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- Iyngkaran, M. Thomas, J. D. Horowitz, P. Komesaroff, M. Jelinek, and D. L. Hare, "Common Comorbidities that Alter Heart Failure Prognosis - Shaping New Thinking for
Practice," CurrCardiol Rev, vol. 17, no. 5, Nov. 2020, doi:
10.2174/1573403x16666201113093548.
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- Alnuwaysir, M. F. Hoes, D. J. van Veldhuisen, P. van der Meer, and N. G. Beverborg, "Iron deficiency in heart failure: Mechanisms and pathophysiology," Journal of Clinical Medicine, vol. 11, no. 1. MDPI, Jan. 01, 2022. doi: 10.3390/jcm11010125.
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- Grote Beverborg, D. J. van Veldhuisen, and P. van der Meer, "Anemia in Heart Failure: Still Relevant?," JACC: Heart Failure, vol. 6, no. 3. Elsevier Inc., pp. 201-208, Mar. 01, 2018. doi:10.1016/j.jchf.2017.08.023.
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- Cleland et al., "Prevalence and outcomes of anemia and hematinic deficiencies in patients with chronic heart failure," JAMA Cardiol, vol. 1, no. 5, pp. 539-547, Aug. 2016, doi:10.1001/jamacardio.2016.1161.
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- Anand and P. Gupta, "Anemia and Iron Deficiency in Heart Failure: Current Concepts and Emerging Therapies," Circulation, vol. 138, no. 1, pp. 80-98, 2018, doi:
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10.1161/CIRCULATIONAHA.118.030099.
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- Correale, S. Paolillo, V. Mercurio, G. Ruocco, C. G. Tocchetti, and A. Palazzuoli, "Non-cardiovascular comorbidities in heart failure patients and their impact on prognosis," Kardiologia Polska, vol. 79, no. 5. Medycyna Praktyczna Cholerzyn, pp. 493-502, Jun. 08, 2021. doi:10.33963/KP.15934.
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- Ponikowski et al., "Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial," The
Lancet, vol. 396, no. 10266, pp.1895-1904, Dec. 2020, doi:
10.1016/S0140-6736(20)32339-4.
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- Kalra et al., "Rationale and design of a randomised trial of intravenous iron in patients with heart failure," Heart, vol. 108, no. 24, pp. 1979-1985, Aug. 2022, doi: 10.1136/heartjnl-2022-321304.
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- Kalra et al., "Intravenous ferric derisomaltose in patients with heart failure and iron deficiency in the UK (IRONMAN): an investigator-initiated, prospective, randomised, open-label, blinded-endpoint trial," The Lancet, vol. 400, no. 10369, pp. 2199-2209, Dec. 2022, doi: 10.1016/S0140-6736(22)02083-9.
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Study Design
Outcome Measures
Primary Outcome Measures
- Iron deficiency [From date of study enrollment until the date of first documented diagnosis of iron deficiency up to 2 weeks.]
A serum ferritin level of <100 ng/ml, or a serum ferritin level of 100-299 ng/ml with a TSAT of < 20% confirms the diagnosis of iron deficiency, regardless of the HB level. TSAT is calculated by the following formula: Serum iron/ TIBC *100.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Heart failure with an ejection fraction of ≤40% within the last 2 years.
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NYHA class II-IV.
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NT-ProBNP >125 pg/ml or BNP ≥35 pg/mL
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Able and willing to provide oral informed consent.
Exclusion Criteria:
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Age<18 years.
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Estimated glomerular filtration rate eGFR <15 mL/min/1.73 m2.
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Acute coronary syndrome.
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Known cases of iron overload (e.g. hemochromatosis); known cases of anemia due to other causes.
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Oral iron supplements within the previous 4 weeks; erythropoietin stimulating agents or blood transfusion within the last 3 months.
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Active clinically relevant bleeding in the investigator's opinion.
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Patients with chronic inflammatory conditions (e.g. rheumatoid arthritis; Crohn's disease, etc.); active infection; and decompensated liver disease.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abdali Hospital | Amman | Jordan | 11145 |
Sponsors and Collaborators
- Jordan Collaborating Cardiology Group
Investigators
- Study Director: Nada Hajjaj, MD, Abdali Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RT.IrnDefHFrEF.Jo001