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| ID | Type | Description | Link |
|---|---|---|---|
| FZK 2025-INV-007 | Other Identifier | University Children's Hospital Zurich - CRC |
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| Name | Class |
|---|---|
| University Children's Hospital, Zurich | OTHER |
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Patients younger than 18 scheduled for congenital heart surgery will be assessed during and post-operatively as well as at the first follow-up after 9-12 month for the novel biomarker sST2. We will assess the marker independently and in evaluation with other blood biomarkers to evaluate sings of heart failure. Compared to established biomarkers, sST2 promises thereby to be less variable to factors like age or acute kidney injury, rendering it potentially more reliable in the field of congenital cardiac surgery.
Single-center prospective biomarker validation study for Soluble suppression of tumorigenicity 2 (sST2). All data will be collected upfront to ensure accuracy. The study's findings aim to improve risk stratification and guide better management for pediatric cardiac surgery patients.
Congenital Heart Disease (CHD) is the most common congenital abnormality, affecting about 1 in 100 live births. While surgical interventions have significantly improved survival rates, a considerable number of patients experience long-term complications like ventricular dysfunction and heart failure, which are major causes of death.
Biomarkers are crucial tools that can aid clinicians in risk stratification, treatment guidance, and predicting outcomes. sST2 has shown utility in adult heart surgery cases and is included in the guidelines of the American Heart Association (AHA), while it's use in pediatric cases is largely unexplored.
This study tests if sST2 as biomarker can be a useful prognostic tool for children with CHD undergoing cardiac surgery. The primary objective is to assess if a specific cut-off level of post-surgery sST2 can predict future heart failure. Secondary objectives include comparing sST2 to other established biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients planned for congenital cardiac surgery | Patients planned for congenital cardiac surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Surrogates of Heart Failure | Correlation of sST2 Levels with compound outcome of number of events of combined events of Death, need for MCS (Mechanical Circulatory Support) or Heart Transplantation | 1 year post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 30 day Mortality | Number of early deaths (30 days post surgery) | 30 days after index operation |
| Overall Length of Stay | Time between operation and discharge from hospital |
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Inclusion Criteria:
Exclusion Criteria:
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All patients in defined age scheduled for congenital cardiac surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Schweiger, Prof, MD, MBA | Contact | +41 44 249 6511 | sst2@kispi.uzh.ch | |
| Clemens Haselmann, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Martin Schweiger, Prof, MD, MBA | University Children's Hospital, Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital Zurirch | Recruiting | Zurich | Canton of Zurich | 8008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32246937 | Background | Parker DM, Everett AD, Stabler ME, Jacobs ML, Jacobs JP, Vricella L, Thiessen-Philbrook H, Parikh CR, Manlhiot C, Brown JR. ST2 Predicts Risk of Unplanned Readmission Within 1 Year After Pediatric Congenital Heart Surgery. Ann Thorac Surg. 2020 Dec;110(6):2070-2075. doi: 10.1016/j.athoracsur.2020.02.056. Epub 2020 Apr 1. | |
| 31648713 |
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Blood
| 30 days after index operation |
| Length of intubation | Days necessary to wean patient from mechanical ventilatory support post surgery. | 30 days after index operation |
| Length of Stay on ICU | Time between operation and discharge from the intensive care unit (ICU) | 30 days after index operation |
| Unplanned hospital re-admission | Binary outcome, if patients is re-admitted for a reason related to his surgical intervention to hospital after being discharged. | 30 days after index operation |
| Signs of upcoming heart failure, determined by cardiac echo | Echocardiographic signs of imminent heart failure | 30 days after index operation |
| Aimo A, Januzzi JL Jr, Bayes-Genis A, Vergaro G, Sciarrone P, Passino C, Emdin M. Clinical and Prognostic Significance of sST2 in Heart Failure: JACC Review Topic of the Week. J Am Coll Cardiol. 2019 Oct 29;74(17):2193-2203. doi: 10.1016/j.jacc.2019.08.1039. |
| 37176577 | Background | Dudek M, Kaluzna-Oleksy M, Migaj J, Sawczak F, Krysztofiak H, Lesiak M, Straburzynska-Migaj E. sST2 and Heart Failure-Clinical Utility and Prognosis. J Clin Med. 2023 Apr 26;12(9):3136. doi: 10.3390/jcm12093136. |
| 31290383 | Background | Brown JR, Stabler ME, Parker DM, Vricella L, Pasquali S, Leyenaar JK, Bohm AR, MacKenzie T, Parikh C, Jacobs ML, Jacobs JP, Everett AD. Biomarkers improve prediction of 30-day unplanned readmission or mortality after paediatric congenital heart surgery. Cardiol Young. 2019 Aug;29(8):1051-1056. doi: 10.1017/S1047951119001471. Epub 2019 Jul 10. |
| 28028009 | Background | Maisel AS, Di Somma S. Do we need another heart failure biomarker: focus on soluble suppression of tumorigenicity 2 (sST2). Eur Heart J. 2017 Aug 7;38(30):2325-2333. doi: 10.1093/eurheartj/ehw462. No abstract available. |