Iron DeficiencyNCT05992116
Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
An observational study of Iron Deficiency and Heart Failure With Reduced Ejection Fraction, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency, Heart Failure With Reduced Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
- How many people
- 450 participants
- Where
- 1 siteJordan
- Study dates
- 1 Sep 2023to 22 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All comers who are adults (18 years of age or older) who have heart failure and an ejection fraction <50%.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of Iron Deficiency in Patients With Heart Failure (HFrEF and HFmrEF) in a Middle Eastern Population
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.
Read the 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.
- 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
- Medical subject headings
- Iron Deficiencies, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of study enrollment until the date of first documented diagnosis of iron deficiency up to 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Sep 2023
- Primary completion15 Jan 2025
- Study completion22 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramzi Tabbalat, Study chair, Abdali Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992116
- Sponsor's protocol ID
- RT.IrnDefHFr.mr.EF.Jo001
- Status last verified
- Mar 2024
- First submitted
- 8 Aug 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Emails and via WhatsApp group to local cardiologists to introc=duce the study to them
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Iron Deficiency in Patients With Heart Failure (HFrEF and HFmrEF) in a Middle Eastern Population
- ClinicalTrials.gov ID
- NCT05992116
- Acronym / sponsor ID
- RT.IrnDefHFr.mr.EF.Jo001
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 22 Feb 2025 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All comers who are adults (18 years of age or older) who have heart failure and an ejection fraction <50%.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Yes. Emails and via WhatsApp group to local cardiologists to introc=duce the study to them
Related trials for Iron Deficiency
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The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
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Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
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The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramzi Tabbalat study chair
Abdali Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency and Heart Failure With Reduced Ejection Fraction, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron deficiency (time frame: From date of study enrollment until the date of first documented diagnosis of iron deficiency up to 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.