Clinical trial NCT03883854: Iron Deficiency in Heart Failure Patients
Official title: Percentage and Spectrum of Iron Deficiency in Systolic Heart Failure Patients in Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: percentage of iron deficiency in systolic heart failure patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.