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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03883854
Other study ID # fh
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 25, 2019
Est. completion date October 20, 2020

Study information

Verified date March 2019
Source Assiut University
Contact Amr Youssef, MD
Phone 0100655404
Email amryousef111@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 quality of life ,and increased mortality


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

1. reduced dietary intake

2. chronic blood loss

3. 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 20, 2020
Est. primary completion date March 26, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

Cleland JG, Khand A, Clark A. The heart failure epidemic: exactly how big is it? Eur Heart J. 2001 Apr;22(8):623-6. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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% 1 year
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