Congenital Heart SurgeryNCT07029230
Blood Based Assessment of sST2, Taken During and After Surgery, for Pediatric Patients With Heart Defects to Predict Heart Failure.
An observational study of Congenital Heart Surgery and Congenital Heart Disease in Children, run by Martin Schweiger at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Heart Surgery, Congenital Heart Disease in Children, Fontan Physiology
- How many people
- 225 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Sep 2025to 31 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients in defined age scheduled for congenital cardiac surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clemens Haselmann, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Children's Hospital Zurirch
Zurich, Canton of Zurich, 8008
Martin Schweiger, Prof, MD, MBA, +41 44 249 6511, sst2@kispi.uzh.ch
Martin Schweiger, Prof, MD, MBA
About this study
Official title: Biomarker in Congenital Cardiac Surgery - sST2 Marker in Heart Failure in Congenital Heart Disease After Surgery Research and Translational Study
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.
Read the detailed description
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.
- Keywords
- biomarker, sst2, congenital heart surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients planned for congenital cardiac surgery | Patients planned for congenital cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year post surgery
Secondary outcomes (6)
30 day Mortality
Number of early deaths (30 days post surgery)
Measured: 30 days after index operation
Overall Length of Stay
Time between operation and discharge from hospital
Measured: 30 days after index operation
Length of intubation
Days necessary to wean patient from mechanical ventilatory support post surgery.
Measured: 30 days after index operation
Length of Stay on ICU
Time between operation and discharge from the intensive care unit (ICU)
Measured: 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.
Measured: 30 days after index operation
Signs of upcoming heart failure, determined by cardiac echo
Echocardiographic signs of imminent heart failure
Measured: 30 days after index operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start10 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart SurgeryStudies 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
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin Schweiger
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital, Zurich
- Responsible party
- Sponsor-investigator, Martin Schweiger, University Children's Hospital, Zurich
- Investigators
- Martin Schweiger, Prof, MD, MBA, Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029230
- Sponsor's protocol ID
- BASEC 2024-01297
- Other IDs
- FZK 2025-INV-007
- Status last verified
- Nov 2025
- First submitted
- 21 May 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32246937Aimo 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.
PubMed 31648713Dudek 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.
PubMed 37176577Brown 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.
PubMed 31290383Maisel 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.
PubMed 28028009
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker in Congenital Cardiac Surgery - sST2 Marker in Heart Failure in Congenital Heart Disease After Surgery Research and Translational Study
- ClinicalTrials.gov ID
- NCT07029230
- Acronym / sponsor ID
- BASEC 2024-01297
- Keywords
- biomarker, sst2, congenital heart surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Martin SchweigerUniversity, hospital or other
- Collaborators
- University Children's Hospital, Zurich
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 19 Jun 2025 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients planned for congenital cardiac surgery | – | –Patients planned for congenital cardiac surgery |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients in defined age scheduled for congenital cardiac surgery
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surrogates of Heart Failure
Time frame: 1 year post surgery
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
6 secondary outcomes
30 day Mortality
Time frame: 30 days after index operation
Overall Length of Stay
Time frame: 30 days after index operation
Length of intubation
Time frame: 30 days after index operation
Length of Stay on ICU
Time frame: 30 days after index operation
Unplanned hospital re-admission
Time frame: 30 days after index operation
Signs of upcoming heart failure, determined by cardiac echo
Time frame: 30 days after index operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Background: PubMed 32246937Parker 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.
- Background: PubMed 31648713Aimo 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.
- Background: PubMed 37176577Dudek 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.
- Background: PubMed 31290383Brown 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.
- Background: PubMed 28028009Maisel 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.
- 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.
Clemens Haselmann, MD contact
Martin Schweiger, Prof, MD, MBA principal investigator
University Children's Hospital, Zurich
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 Surgery and Congenital Heart Disease in Children, run by Martin Schweiger at 1 site in Switzerland.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Nov 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Schweiger, Prof, MD, MBA (+41 44 249 6511, sst2@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surrogates of Heart Failure (time frame: 1 year post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07029230, which also lists 5 linked publications.
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 17 Nov 2025.