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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05992116

Enrollment

450

Registered

2023-08-15

Start date

2023-09-01

Completion date

2025-02-22

Last updated

2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Mildly Reduced Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Iron Deficiency

Keywords

Iron deficiency, Heart failure, Heart failure with reduced ejection fraction, Heart failure with mildly reduced ejection fraction

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Jordan

Outcome results