Heart FailureNCT03883854
Iron Deficiency in Heart Failure Patients
An observational study of Heart Failure, run by Assiut University.
Trial summary
Heart failure is a common problem with a prevalence of 1-2% in general population and a major cause of mortality,morbidity and impaired quality of life. Anemia is afrequent comorbidity in stable heart failure patients and it increases morbidity in terms of frequent hospital admissions,impaired exercise capacity,poor… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2019to 20 Oct 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: all participants will undergoe 1. full history(including dietary history) 2. clinical examination. 3. transthoracic echocardiography:for measurement of ejection fraction 4. complete blood count 5. complete iron profile: serum iron -serum ferritin-total iron binding capacity-transferrin saturation.
Who may be able to join
- .100 males or females patients above age of 18years of age and clinically diagnosed with systolic heart failure,ejection fraction<50% by echocardiography admitted in Assiut University hospital
Who cannot join
- .Known to be non cardiac condition causing iron deficiency(haemorrhoids,malignancy).
- .other conditions causing fluid overload(eg.renal failure on dialysis ). .congenital heart disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Percentage and Spectrum of Iron Deficiency in Systolic Heart Failure Patients in Assiut University Hospital
Heart failure is a common problem with a prevalence of 1-2% in general population and a major cause of mortality,morbidity and impaired quality of life. Anemia is afrequent comorbidity in stable heart failure patients and it increases morbidity in terms of frequent hospital admissions,impaired exercise capacity,poor quality of life ,and increased mortality
Read the detailed description
Iron deficiency with or without anemia has been commonly associated with heart failure .Although iron deficiency is the commonest nutritional deficiency worldwide ,affecting more than one-third of the population,its association with heart failure with or without anemia is of growing interest .As iron supplementation improves prognosis in patients with heart failure ,iron deficiency is an attractive therapeutic target.
In 2012 ,the European society of cardiology Guidelines for the diagnosis and treatment of acute and chronic heart failure recognized iron deficiency as a comorbidity in heart failure for the first time and recommended diagnosis of iron deficiency based on iron parameters in all patients suspected of having heart failure.
Iron deficiency can be classified as absolute or functional. Absolute iron deficiency reflects depleted body stores caused by poor dietary intake, impaired gastrointestinal absorption,and chronic blood loss.
Functional iron deficiency is thought to be caused by increased hepcidin production and subsequent inhibition of the iron exporter ferroportin ,leading to impaired absorption and utilization of iron.
Chronic heart failure patients are susceptible to both forms iron deficiency
Aetiology of iron deficiency in chronic heart failure:
The aetiology is multifactorial and complex
- reduced dietary intake
- chronic blood loss
- chronic heart failure causes an inflammatory state which leads to increased hepcidin levels and subsequent iron deficiency due to reduced iron absorption and enhanced reticuloendothelial block
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 group | Complete iron profile * serum iron * serum ferritin * total iron binding capacity * transferrin saturation (TSAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of iron deficiency in systolic heart failure patients
systolic heart failure is defined as ejection fraction <50% absolute iron deficiency is serum ferritin<100ug/l.Functional iron deficiency is defined as normal serum ferritin(100-300)ug/l with low transferrin saturation<20%
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start25 Mar 2019 (estimated)
- Primary completion26 Mar 2020 (estimated)
- Study completion20 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essam Nan Saleeb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883854
- Sponsor's protocol ID
- fh
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2019
- Last updated
- 22 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cleland JG, Khand A, Clark A. The heart failure epidemic: exactly how big is it? Eur Heart J. 2001 Apr;22(8):623-6. doi: 10.1053/euhj.2000.2493. No abstract available.
PubMed 11286518
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percentage and Spectrum of Iron Deficiency in Systolic Heart Failure Patients in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT03883854
- Acronym / sponsor ID
- fh
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Mar 2019 (estimated)
- Primary completion
- 26 Mar 2020 (estimated)
- Study completion
- 20 Oct 2020 (estimated)
- First posted
- 21 Mar 2019 (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.
Heart failure is a common problem with a prevalence of 1-2% in general population and a major cause of mortality,morbidity and impaired quality of life. Anemia is afrequent comorbidity in stable heart failure patients and it increases morbidity in terms of frequent hospital admissions,impaired exercise capacity,poor quality of life ,and increased mortality
Detailed description
Iron deficiency with or without anemia has been commonly associated with heart failure .Although iron deficiency is the commonest nutritional deficiency worldwide ,affecting more than one-third of the population,its association with heart failure with or without anemia is of growing interest .As iron supplementation improves prognosis in patients with heart failure ,iron deficiency is an attractive therapeutic target.
In 2012 ,the European society of cardiology Guidelines for the diagnosis and treatment of acute and chronic heart failure recognized iron deficiency as a comorbidity in heart failure for the first time and recommended diagnosis of iron deficiency based on iron parameters in all patients suspected of having heart failure.
Iron deficiency can be classified as absolute or functional. Absolute iron deficiency reflects depleted body stores caused by poor dietary intake, impaired gastrointestinal absorption,and chronic blood loss.
Functional iron deficiency is thought to be caused by increased hepcidin production and subsequent inhibition of the iron exporter ferroportin ,leading to impaired absorption and utilization of iron.
Chronic heart failure patients are susceptible to both forms iron deficiency
Aetiology of iron deficiency in chronic heart failure:
The aetiology is multifactorial and complex
- reduced dietary intake
- chronic blood loss
- chronic heart failure causes an inflammatory state which leads to increased hepcidin levels and subsequent iron deficiency due to reduced iron absorption and enhanced reticuloendothelial block
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 group | – | –Complete iron profile * serum iron * serum ferritin * total iron binding capacity * transferrin saturation (TSAT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all participants will undergoe 1. full history(including dietary history) 2. clinical examination. 3. transthoracic echocardiography:for measurement of ejection fraction 4. complete blood count 5. complete iron profile: serum iron -serum ferritin-total iron binding capacity-transferrin saturation.
Key inclusion criteria (1 listed)
- .100 males or females patients above age of 18years of age and clinically diagnosed with systolic heart failure,ejection fraction<50% by echocardiography admitted in Assiut University hospital
Key exclusion criteria (2 listed)
- .Known to be non cardiac condition causing iron deficiency(haemorrhoids,malignancy).
- .other conditions causing fluid overload(eg.renal failure on dialysis ). .congenital heart disease.
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
percentage of iron deficiency in systolic heart failure patients
Time frame: 1 year
systolic heart failure is defined as ejection fraction <50% absolute iron deficiency is serum ferritin<100ug/l.Functional iron deficiency is defined as normal serum ferritin(100-300)ug/l with low transferrin saturation<20%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Results publication: PubMed 11286518Cleland JG, Khand A, Clark A. The heart failure epidemic: exactly how big is it? Eur Heart J. 2001 Apr;22(8):623-6. doi: 10.1053/euhj.2000.2493. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Assiut University.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr Youssef, MD (0100655404, amryousef111@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of iron deficiency in systolic heart failure patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03883854, which also lists 1 linked publication.
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 22 Mar 2019.