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Completed

NCT Number: NCT05992116

Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction

A significant percentage of patients with heart failure and reduced ejection fraction (HFrEF) or mildly reduced ejection fraction (HFmrEF) 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 and HFmrEF patients in Jordan has not been studied in the past.

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Key information

About this study

The prevalence of chronic heart failure among the industrialized countries is 1-3%, and can exceed 30% in the elderly population. As the population ages, there is an increase in the number of co-morbidities among heart failure patients. These comorbidities are associated with an increase in major adverse cardiac events (MACE), cost, and complexity of care. 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. The relationship between the severity of iron deficiency and the prognosis is a linear one, with increased severity being associated with increased mortality.

Intravenous iron treatment has been shown to improve the quality of life, with an increased exercise capacity and a reduced risk for hospitalizations. The prevalence of iron deficiency in HFrEF and HFmrEF patients in Middle Eastern population has not been studied. We suspect a higher prevalence compared to Western populations especially in women.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Heart failure patients with ejection fraction <59% (including those with with reduced ejection fraction of ≤40%, or mildly reduced EF (41-49%)) within the last 2 years.
  • NYHA class II-IV.
  • Able and willing to provide oral informed consent.

Exclusion criteria

  • Age<18 years.
  • Acute coronary syndrome.
  • Known cases of iron overload (e.g. hemochromatosis); known cases of anemia due to other causes.
  • Oral or intravenous iron supplements within the previous 3 months; erythropoietin stimulating agents or blood transfusion within the last 6 months.
  • Active clinically relevant bleeding in the investigator's opinion.
  • Patients with chronic inflammatory conditions (e.g. rheumatoid arthritis; Crohn's disease, etc.); active infection; and decompensated liver disease.

Treatment and study plan

Primary outcomes

  1. Iron deficiency

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jordan Collaborating Cardiology Group

Other

Registry information

Official study title

The Prevalence of Iron Deficiency in Patients With Heart Failure (HFrEF and HFmrEF) in a Middle Eastern Population

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2023
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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