The Level of sST2 in Pediatric Heart Failure

Congestive Heart Failure Clinical Trial

Official title:

Does the Level of ST2 in Pediatric Heart Failure Patients Indicate the Likelihood of Cardiovascular Events and Mortality?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06347510
• Other study ID #: E-25403353-050.99-174660
• Status: Completed
• Start date: August 16, 2021
• Est. completion date: February 16, 2024

Study information

• Verified date: April 2024
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Introduction: Suppression of tumorigenicity 2 (ST2) is a receptor member belongs to the Interleukin-1 (IL-1) family. The ligand and soluble versions are its two isoforms. The interleukin-33-ST2 ligand complexs development provides protection against heart fibrosis and hypertrophy. Investigations on heart failure in adults has demonstrated that it does not change by age, body mass index (BMI), creatinine, hemoglobin, and albumin levels, in contrast to NT pro brain natriuretric peptit. In adult heart failure patients, it has been demonstrated to be an independent predictor of mortality and cardiovascular events. The most recent guideline recommends using it as class 2b in the diagnosis of adult heart failure. Studies on ST2 in children are rare. The purpose of this study is to assess the prognostic value of ST2 for cardiovascular events in young individuals suffering from heart failure.

Method: The study included pediatric patients (0-18 years old) with congenital heart disease or cardiomyopathy who needed medical care as well as surgical or interventional treatment. Height, weight, gender, saturation, heart failure classification (Ross or New York heart Assosiation), medications taken, the electrocardiogram, echocardiography, Pro BNP, and sST2 values of the patients, as well as any hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery during follow-up Data on arrhythmia and death were gathered during a 1-year follow-up. The SPSS software application was used to carry out the statistical analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 16, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• The patients were those with congenital cardiac disease or cardiomyopathy who needed medical care as well as surgical or interventional treatment.

Exclusion Criteria:

• . Excluded from the trial were individuals who had undergone cardiac surgery within past one month, had chronic renal failure, septic shock, myocardial dysfunction related to cardiopulmonary resuscitation, or for whom consent could not be received.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Congestive Heart Failure
• Heart Defects, Congenital
• Heart Diseases
• Heart Failure

Intervention

Diagnostic Test:
• Suppression of tumorigenicity 2 (ST2)
Suppression of tumorigenicity 2 (ST2) is a member of the interleukin-1 (IL-1) receptor family. The ligand and soluble versions are its two isoforms. It was first isolated in 1989. It was found to function as an IL-33 ligand in 2005. The IL-33-ST2L ligand complex's creation offers protection against heart fibrosis and hypertrophy. The formation of this complex is inhibited by soluble ST2, which removes the cardioprotective effect. Unlike NT pro BNP, it is unaffected by age, body mass index, creatinine, hemoglobin, and albumin levels, according to studies performed on individuals. with heart failure.

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University	Eskisehir	Odunpazari

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soluble suppression of tumorigenicity levels with or without major cardiovascular event	pg/ml	baseline
Primary	Pro BNP levels	pg/ml	baseline
Primary	Major cardiovascular event ( such as hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery)	rate(%)	1 year follow up