NCT06347510

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

2.5 years

First QC Date

March 26, 2024

Last Update Submit

April 2, 2024

Conditions

Keywords

Suppression of tumorigenicity 2 (ST2)congenital heart diseasecongestive heart failure

Outcome Measures

Primary Outcomes (3)

  • Soluble suppression of tumorigenicity levels with or without major cardiovascular event

    pg/ml

    baseline

  • Pro BNP levels

    pg/ml

    baseline

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

    rate(%)

    1 year follow up

Interventions

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.

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The study was conducted in Eskisehir Osmangazi University Pediatric cardiology clinic

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Defects, CongenitalHeart Failure

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor/ Pediatric Cardiology

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 4, 2024

Study Start

August 16, 2021

Primary Completion

February 16, 2024

Study Completion

February 16, 2024

Last Updated

April 4, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations