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Status unknownNCT04104061Updated Sep 26, 2019

Iron Profile in Patients With Congenital Cyanotic Heart Disease

An observational study in Congenital; Cyanotic Heart Disease, sponsored by Assiut University. Status unknown. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2019-09-26.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
30
Ages
1 Month to 18 Years
Sex
All
01

Study summary

Iron is a vital substrate for hemoglobin production and sufficient iron stores are necessary to achieve and maintain adequate levels of hemoglobin.

Read the detailed description

Iron is a vital substrate for hemoglobin production and sufficient iron stores are necessary to achieve and maintain adequate levels of hemoglobin. Unfortunately, more than one third of patients with cyanotic heart disease are iron-deficient (1),(2). In 1990, West et al, have demonstrated that more than one-third of patients with congenital cyanotic heart diseases (CCHD) had iron deficiency(3) In another study done by Olcay et al, the prevalence of iron deficiency anemia (IDA) was found to be 52.2%(4).

Possible causes of iron deficiency include increased iron consumption through increased erythropoiesis, inappropriate venesections, hemoptysis, bleeding from arteriovenous malformations or collateral vessels, abnormal hemostasis, limited dietary intake or absorption, and use of anticoagulants and antiplatelets (5).

Also congenital cyanotic heart lesions are associated with a state of constant hypoxia This hypoxia triggers a physiological increase in erythropoietin release leading to stimulation of the bone marrow to produce more red cells in an effort to increase the body's oxygen carrying capacity, so as to improve oxygen delivery to the tissues. With persisting right to left shunt, the arterial oxygen tensions remain perpetually low and so the production of more and more red cells goes unabated leading to polycythemia. This seemingly noble physiological response eventually leads to depletion of iron stores (6).

In these patients, the total haemoglobin is normal, high or slightly reduced compared to aged-matched normal individuals without cyanosis. However, the MCV, MCH and serum ferritin are usually comparatively lower than their peers as shown by Cemile et al - a phenomenon known as relative anemia (7).

In fact, traditional diagnostic criteria for anemia do not apply to these patients, where "appropriate" levels of hemoglobin may vary according to their oxygen saturations (8). Also, other erythrocyte indices such as MCV and MCH are not sensitive indicators of iron deficiency in cyanotic patients (9).

IDA aggravates hyperviscosity symptoms due to the presence of microcytic erythrocytes not amenable to deformation in the microcirculation. Thus, presence of IDA in these children further increases their chances of morbidity in the form of cerebrovascular events and cyanotic spells (10).

The high incidence of iron deficiency among children with CCHD draws attention to the importance of evaluating iron deficiency in this population.

02

Conditions studied

  • Congenital; Cyanotic Heart Disease
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

infants and n with congenital cyanotic heart disease

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- 1. Age: 1month to 18 years 2. Pediatric patients attending and admitted to Assuit University Children Hospital and diagnosed to have congenital cyanotic heart disease evidenced by clinical picture and echocardiography.

3. Both sexes.

Exclusion criteria

Exclusion Criteria:

  • 1. Patients with acyanotic congenital heart disease. 2. Patients who had surgical correction. 3. Patients who received iron supplements in previous three months. 4. Patients who have another systemic disease that affect iron profile and cause anemia as Chronic kidney disease or Hemolytic anemia
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • Otheriron profile

    blood test

    Also known as: complete blood count

06

What researchers measure

Primary outcomes

  1. iron profile in patients with congenital cyanotic heart disease

    iron profile in patients with congenital cyanotic heart disease

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Mukherjee S, Sharma M, Devgan A, Jatana SK. Iron deficiency anemia in children with cyanotic congenital heart disease and effect on cyanotic spells. Med J Armed Forces India. 2018 Jul;74(3):235-240. doi: 10.1016/j.mjafi.2017.07.003. Epub 2017 Aug 18. PubMed 30093766 ↗
  • Lang'o MO, Githanga JN, Yuko-Jowi CA. Prevalence of iron deficiency in children with cyanotic heart disease seen at Kenyatta National Hospital and Mater Hospital Nairobi. East Afr Med J. 2009 Dec;86(12 Suppl):S47-51. doi: 10.4314/eamj.v86i12.62901. PubMed 21591509 ↗
  • Tay EL, Peset A, Papaphylactou M, Inuzuka R, Alonso-Gonzalez R, Giannakoulas G, Tzifa A, Goletto S, Broberg C, Dimopoulos K, Gatzoulis MA. Replacement therapy for iron deficiency improves exercise capacity and quality of life in patients with cyanotic congenital heart disease and/or the Eisenmenger syndrome. Int J Cardiol. 2011 Sep 15;151(3):307-12. doi: 10.1016/j.ijcard.2010.05.066. Epub 2010 Jul 1. PubMed 20580108 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2019; primary completion for Oct 2020, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 24, 2019
First posted
Sep 26, 2019
StartEst.
Oct 1, 2019
Primary completionEst.
Oct 1, 2020
CompletionEst.
Oct 1, 2021
Last update
Sep 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04104061
Lead sponsor
Assiut University
Responsible party
Esraa Sami Abdelrahman (principal investigator, Assiut University) — Principal investigator
First posted
Sep 26, 2019
Start date
Oct 1, 2019 (estimated)
Primary completion
Oct 1, 2020 (estimated)
Completion
Oct 1, 2021 (estimated)
Last update
Sep 26, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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