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

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992116
• Other study ID #: RT.IrnDefHFr.mr.EF.Jo001
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Jordan Collaborating Cardiology Group
• Contact: Ramzi Tabbalat, MD, FACC
• Phone: 00962795535522
• Email: ramzi_md[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 28, 2025
• Est. primary completion date: September 15, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Iron Deficiency

Locations

Country	Name	City	State
Jordan	Abdali Hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Jordan Collaborating Cardiology Group

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron deficiency	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.	From date of study enrollment until the date of first documented diagnosis of iron deficiency up to 2 weeks.