- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06347510
The Level of sST2 in Pediatric Heart Failure
Does the Level of ST2 in Pediatric Heart Failure Patients Indicate the Likelihood of Cardiovascular Events and Mortality?
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Odunpazarı
-
Eskisehir, Odunpazarı, Turkey, 26040
- Eskisehir Osmangazi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Soluble suppression of tumorigenicity levels with or without major cardiovascular event
Time Frame: baseline
|
pg/ml
|
baseline
|
|
Pro BNP levels
Time Frame: baseline
|
pg/ml
|
baseline
|
|
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(%)
|
1 year follow up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-25403353-050.99-174660
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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