ST2 Predicts Risk of Unplanned Readmission Within 1 Year After Pediatric Congenital Heart Surgery.
Devin M Parker, Allen D Everett, Meagan E Stabler...
https://pubmed.ncbi.nlm.nih.gov/32246937Actively Recruiting
Age: 0 - 18Years
All Genders
ID07029230
Biomarker in Congenital Cardiac Surgery - sST2 Marker in Heart Failure in Congenital Heart Disease After Surgery Research and Translational Study
Led by Martin Schweiger · Updated on 2025-11-17
225
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
M
Martin Schweiger
Lead Sponsor
U
University Children's Hospital, Zurich
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on children under 18 years old scheduled for congenital heart surgery. It aims to evaluate the usefulness of a new blood biomarker called soluble suppression of tumorigenicity 2 (sST2) in predicting heart failure. The study compares sST2 to other established biomarkers, seeking to improve risk assessment and management for pediatric patients with congenital heart disease, a common birth defect that can lead to serious heart complications after surgery. Participants are children planned for congenital cardiac surgery. Blood samples for sST2 and other biomarkers will be collected during surgery, post-operatively, and again at a follow-up visit 9 to 12 months later. The study observes the levels of sST2 independently and alongside other markers to assess its reliability, as sST2 may be less affected by factors like age or acute kidney injury. Throughout the study, patients will be monitored for signs of heart failure through clinical data, cardiac imaging, and hospital records within the first year after surgery. Researchers will track outcomes such as mortality, length of hospital stay, time on ventilation, ICU stay, and unplanned readmissions. The main measurement is the presence of heart failure signs one year after surgery, helping to better predict long-term risks for these children.
CONDITIONS
Brief Title
Blood Based Assessment of sST2, Taken During and After Surgery, for Pediatric Patients With Heart Defects to Predict Heart Failure.
Who Can Participate
Age: 0 - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Consented for cardiopulmonary bypass surgery for cardiac reason
- Conversational skills in German (by child and/or representative) to be able to fully understand and sign a written consent in German language
You will not qualify if you...
- Known genetic life limiting conditions
- Syndrome patients who are scheduled or highly likely to be operated on more than one organ
- Body weight at time of surgery less than 2.5 kg
- Being recruited and enrolled for an interventional study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Hospital stay around surgery (up to 30 days)
Participants undergo congenital cardiac surgery with biomarker assessments during and immediately after surgery to evaluate sST2 levels.
Visits during hospitalization including surgery day and immediate post-operative period
Post-operative Follow-up
Duration - 30 days after surgery
Participants are monitored after surgery to assess heart function and signs of heart failure using clinical and biomarker evaluations.
Follow-up visits up to 30 days post-surgery
Long-term Monitoring
Duration - Up to 1 year post surgery
Participants are followed for up to one year after surgery to evaluate surrogates of heart failure and long-term outcomes.
Periodic visits during the first year after surgery
Trial Site Locations
Total: 1 location
1
University Children's Hospital Zurirch
Zurich, Canton of Zurich, Switzerland, 8008
Actively Recruiting
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Research Team
M
Martin Schweiger, Prof, MD, MBA
C
Clemens Haselmann, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Clinical and Prognostic Significance of sST2 in Heart Failure: JACC Review Topic of the Week.
Alberto Aimo, James L Januzzi, Antoni Bayes-Genis...
https://pubmed.ncbi.nlm.nih.gov/31648713sST2 and Heart Failure-Clinical Utility and Prognosis.
Magdalena Dudek, Marta Kałużna-Oleksy, Jacek Migaj...
https://pubmed.ncbi.nlm.nih.gov/37176577Biomarkers improve prediction of 30-day unplanned readmission or mortality after paediatric congenital heart surgery.
Jeremiah R Brown, Meagan E Stabler, Devin M Parker...
https://pubmed.ncbi.nlm.nih.gov/31290383Do we need another heart failure biomarker: focus on soluble suppression of tumorigenicity 2 (sST2).
Alan S Maisel, Salvatore Di Somma
https://pubmed.ncbi.nlm.nih.gov/28028009