- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03883854
Iron Deficiency in Heart Failure Patients
Percentage and Spectrum of Iron Deficiency in Systolic Heart Failure Patients in Assiut University Hospital
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Amr Youssef, MD
- Phone Number: 0100655404
- Email: amryousef111@yahoo.com
Study Contact Backup
- Name: Ayman Hassan, MD
- Phone Number: 0109443805
- Email: Ayman.hassan@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
all participants will undergoe
- full history(including dietary history)
- clinical examination.
- transthoracic echocardiography:for measurement of ejection fraction
- complete blood count
- complete iron profile: serum iron -serum ferritin-total iron binding capacity-transferrin saturation.
Description
Inclusion Criteria:
.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
Exclusion Criteria:
.Known to be non cardiac condition causing iron deficiency(haemorrhoids,malignancy).
.other conditions causing fluid overload(eg.renal failure on dialysis ). .congenital heart disease.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
1 group
Complete iron profile
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- fh
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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