Blood sST2 testing to predict heart failure after pediatric congenital heart surgery
Official title: Biomarker in Congenital Cardiac Surgery - sST2 Marker in Heart Failure in Congenital Heart Disease After Surgery Research and Translational Study
Run by University Children's Hospital, Zurich · NCT07029230 · Data updated 2026-11-12
We will test whether blood levels of the biomarker sST2 taken during and after heart surgery can help predict future heart failure in children with congenital heart disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 225 (estimated) |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Status | Recruiting |
| Started | September 10, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | January 31, 2029 |
| Registry record updated | November 17, 2025 |
| Trial ID | NCT07029230 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children under 18 scheduled for cardiopulmonary bypass congenital heart surgery who (or whose guardians) can consent in German, weigh at least 2.5 kg, do not have known life-limiting genetic conditions, and are not enrolled in an interventional protocol are the ideal candidates.
✕Probably not a fit
Patients with known life-limiting genetic conditions, those expected to require multi-organ surgery, infants under 2.5 kg, or subjects already enrolled in an interventional study are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective biomarker validation effort enrolling children under 18 undergoing cardiopulmonary bypass for congenital heart surgery. Blood samples will be taken during the perioperative period, after surgery, and at a 9–12 month follow-up to measure soluble ST2 (sST2) and compare it with established biomarkers. The primary aim is to identify a post-surgery sST2 cutoff that predicts later development of heart failure, and secondary analyses will compare sST2's performance to other markers. All data are collected prospectively at the University Children's Hospital Zurich to improve accuracy and support risk-stratified care.
Why it matters
Potential benefit: If sST2 reliably predicts heart failure risk, it could enable earlier interventions and more personalized follow-up for children after cardiac surgery.
How similar studies have gone: sST2 has shown clinical utility in adult cardiac populations and is referenced in AHA guidance, but its use in pediatric congenital heart surgery is largely untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Know 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
Where it's running
-
University Children's Hospital Zurirch
Zurich, Canton of Zurich, Switzerland Recruiting
Study contacts
- Principal investigator: Martin Schweiger, Prof, MD, MBA — University Children's Hospital, Zurich
- Study coordinator: Martin Schweiger, Prof, MD, MBA
- Email: sst2@kispi.uzh.ch
- Phone: +41 44 249 6511
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.