Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
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| ClinicalTrials.gov Identifier: NCT05992116 |
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Recruitment Status :
Recruiting
First Posted : August 15, 2023
Last Update Posted : March 13, 2024
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| Condition or disease |
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| Iron Deficiency Heart Failure With Reduced Ejection Fraction Heart Failure With Mildly Reduced Ejection Fraction |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | The Prevalence of Iron Deficiency in Patients With Heart Failure (HFrEF and HFmrEF) in a Middle Eastern Population |
| Actual Study Start Date : | September 1, 2023 |
| Estimated Primary Completion Date : | September 15, 2024 |
| Estimated Study Completion Date : | February 28, 2025 |
- Iron deficiency [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05992116
| Contact: Ramzi Tabbalat, MD, FACC | 00962795535522 | ramzi_md@yahoo.com | |
| Contact: Ahmad Alkhatib, MD | 0096265109999 | ramzi.tabbalat@abdalimedical.com |
| Jordan | |
| Abdali Hospital | Recruiting |
| Amman, Jordan, 11145 | |
| Contact: Ramzi Tabbalat, MD FACC 00962795525522 ramzi_md@yahoo.com | |
| Contact: Ahmad Alkhatib, MD 0096265109999 ramzi.tabbalat@abdalimedical.com | |
| Study Director: | Nada Hajjaj, MD | Abdali Hospital |
| Responsible Party: | Jordan Collaborating Cardiology Group |
| ClinicalTrials.gov Identifier: | NCT05992116 |
| Other Study ID Numbers: |
RT.IrnDefHFr.mr.EF.Jo001 |
| First Posted: | August 15, 2023 Key Record Dates |
| Last Update Posted: | March 13, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Emails and via WhatsApp group to local cardiologists to introc=duce the study to them |
| Supporting Materials: |
Study Protocol Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Time Frame: | After clinicaltrials.gov sends us an identifier number |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Iron deficiency Heart failure Heart failure with reduced ejection fraction Heart failure with mildly reduced ejection fraction |
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Heart Failure Anemia, Iron-Deficiency Iron Deficiencies Heart Diseases Cardiovascular Diseases |
Iron Metabolism Disorders Metabolic Diseases Anemia, Hypochromic Anemia Hematologic Diseases |