The Association Between Anemia and Cardiomegaly

Anemia in Children Clinical Trial

Official title:

The Association Between Anemia (Hemoglobin Level) and Cardiomegaly Based On Chest Radiograph and Echocardiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816278
• Other study ID #: 001
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2023
• Source: Universitas Sumatera Utara
• Contact: Putri Amelia
• Phone: +6285261000273
• Email: putri.amelia[@]usu.ac.id
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Anemia is one of the major global problems that continues to this day. According to World Health Organization (WHO) data, anemia is found in 1.62 billion people or equivalent to 24.8% of the world's population while, the prevalence of anemia in children under 6 years of age in Indonesia reached 38.4%. Anemia, if undiagnosed or untreated for a long period of time can lead to multiorgan failure. The cardiovascular system is the most commonly affected system in chronic anemia. Between one-third and two-thirds of patients with severe anemia have cardiomegaly and this will return to normal within a few weeks after the anemia is well managed. This abnormality can be evaluated on chest radiograph or echocardiography.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: September 1, 2023
• Est. primary completion date: July 1, 2023
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

Inclusion Criteria:

• Anemia patients aging maximum 18 years old
• Anemia patients who had undergone chest radiograph and echocardiography

Exclusion Criteria:

• Anemia patients who had undergone definitive surgery
• Anemia patients who had took iron supplementation in the last 3 months
• Anemia patients who had other anemic conditions such as chronic kidney disease or hemolytic anemia

Related Conditions & MeSH terms

• Anemia
• Anemia in Children
• Cardiomegaly

Locations

Country	Name	City	State
Indonesia	Universitas Sumatera Utara	Medan	North Sumatera

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Sumatera Utara

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia	Diagnosis of anemia based on Hb levels according to WHO classification	April 2023 - September 2023
Primary	Cardiomegaly	Diagnosis of cardiomegaly based on chest radiograph and echocardiography	April 2023 - September 2023