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Completed

NCT Number: NCT06347510

The Level of sST2 in Pediatric Heart Failure

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eskisehir Osmangazi University

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suppression of tumorigenicity 2 (ST2)

Diagnostic Test

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.

Primary outcomes

  1. Soluble suppression of tumorigenicity levels with or without major cardiovascular event

    Time frame: baseline

    pg/ml

  2. Pro BNP levels

    Time frame: baseline

    pg/ml

  3. Major cardiovascular event ( such as hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery)

    Time frame: 1 year follow up

    rate(%)

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 4, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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