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

Last updated: March 10, 2024
Sponsor: Jordan Collaborating Cardiology Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Heart Failure

Treatment

N/A

Clinical Study ID

NCT05992116
RT.IrnDefHFr.mr.EF.Jo001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Heart failure patients with ejection fraction <59% (including those with with reducedejection 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

Exclusion Criteria:

  • Age<18 years.
  • Acute coronary syndrome.
  • Known cases of iron overload (e.g. hemochromatosis); known cases of anemia due toother causes.
  • Oral or intravenous iron supplements within the previous 3 months; erythropoietinstimulating 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'sdisease, etc.); active infection; and decompensated liver disease.

Study Design

Total Participants: 500
Study Start date:
September 01, 2023
Estimated Completion Date:
February 28, 2025

Study Description

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.

Connect with a study center

  • Abdali Hospital

    Amman, 11145
    Jordan

    Active - Recruiting

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