Congenital Heart DiseaseNCT06347510
The Level of sST2 in Pediatric Heart Failure
An observational study of Congenital Heart Disease and Congestive Heart Failure, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Congenital Heart Disease, Congestive Heart Failure
- What is being tested?
- Suppression of tumorigenicity 2 (ST2)
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Aug 2021to 16 Feb 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study was conducted in Eskisehir Osmangazi University Pediatric cardiology clinic
Who may be able to join
- The patients were those with congenital cardiac disease or cardiomyopathy who needed medical care as well as surgical or interventional treatment.
Who cannot join
- . 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, Odunpazarı, 26040
About this study
Official title: 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.
- Conditions
- Congenital Heart Disease, Congestive Heart Failure
- Being tested
- Suppression of tumorigenicity 2 (ST2)
- Keywords
- Suppression of tumorigenicity 2 (ST2), congenital heart disease, congestive heart failure
- Medical subject headings
- Heart Defects, Congenital, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Soluble suppression of tumorigenicity levels with or without major cardiovascular event
pg/ml
Measured: baseline
Pro BNP levels
pg/ml
Measured: baseline
Major cardiovascular event ( such as hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery)
rate(%)
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start16 Aug 2021
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Sulu, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347510
- Sponsor's protocol ID
- E-25403353-050.99-174660
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Level of ST2 in Pediatric Heart Failure Patients Indicate the Likelihood of Cardiovascular Events and Mortality?
- ClinicalTrials.gov ID
- NCT06347510
- Acronym / sponsor ID
- E-25403353-050.99-174660
- Conditions
- Congenital Heart Disease, Congestive Heart Failure
- Keywords
- Suppression of tumorigenicity 2 (ST2), congenital heart disease, congestive heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study was conducted in Eskisehir Osmangazi University Pediatric cardiology clinic
Key inclusion criteria (1 listed)
- The patients were those with congenital cardiac disease or cardiomyopathy who needed medical care as well as surgical or interventional treatment.
Key exclusion criteria (1 listed)
- . 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
Soluble suppression of tumorigenicity levels with or without major cardiovascular event
Time frame: baseline
pg/ml
Pro BNP levels
Time frame: baseline
pg/ml
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(%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Congestive Heart Failure, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soluble suppression of tumorigenicity levels with or without major cardiovascular event (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.