Clinical trial NCT06347510: The Level of sST2 in Pediatric Heart Failure
Official title: Does the Level of ST2 in Pediatric Heart Failure Patients Indicate the Likelihood of Cardiovascular Events and Mortality?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Congestive Heart Failure
Keywords: Suppression of tumorigenicity 2 (ST2)
congenital heart disease
congestive heart failure
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 59
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study was conducted in Eskisehir Osmangazi University Pediatric cardiology clinic

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Soluble suppression of tumorigenicity levels with or without major cardiovascular event
timeFrame: baseline
measure: Pro BNP levels
timeFrame: baseline
measure: Major cardiovascular event ( such as hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery)
timeFrame: 1 year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
state: Odunpazarı
Study officials:
References: