Iron Deficiency in Heart Failure Patients

March 20, 2019 updated by: Essam Nan Saleeb, Assiut University

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

Study Overview

Status

Unknown

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

  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

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1 group

Complete iron profile

  • serum iron
  • serum ferritin
  • total iron binding capacity
  • transferrin saturation (TSAT)

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 25, 2019

Primary Completion (Anticipated)

March 26, 2020

Study Completion (Anticipated)

October 20, 2020

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

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

No

Studies a U.S. FDA-regulated device product

No

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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