Clinical trial NCT05992116: Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
Official title: The Prevalence of Iron Deficiency in Patients With Heart Failure (HFrEF and HFmrEF) in a Middle Eastern Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency
Heart Failure With Reduced Ejection Fraction
Heart Failure With Mildly Reduced Ejection Fraction
Keywords: Iron deficiency
Heart failure
Heart failure with reduced ejection fraction
Heart failure with mildly reduced ejection fraction
Lead sponsor: Jordan Collaborating Cardiology Group
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All comers who are adults (18 years of age or older) who have heart failure and an ejection fraction \<50%.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Iron deficiency
timeFrame: From date of study enrollment until the date of first documented diagnosis of iron deficiency up to 2 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Abdali Hospital
Study officials:
affiliation: Abdali Hospital
name: Ramzi Tabbalat
role: STUDY_CHAIR
References: