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

NCT05992116 | Completed

• 1 other identifier: RT.IrnDefHFr.mr.EF.Jo001
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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%.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordan Collaborating Cardiology Group: lead

Study Sites (1)

Abdali Hospital

Amman, 11145, Jordan

Location

MeSH Terms

Conditions

Iron Deficiencies; Heart Failure

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Ramzi Tabbalat

  Abdali Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 15, 2023
• Study Start: September 1, 2023
• Primary Completion: January 15, 2025
• Study Completion: February 22, 2025
• Last Updated: February 25, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After clinicaltrials.gov sends us an identifier number

Locations

JO (1)