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NCT Number: NCT07029230

Blood Based Assessment of sST2, Taken During and After Surgery, for Pediatric Patients With Heart Defects to Predict Heart Failure.

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Zurirch

Zurich, Canton of Zurich, 8008, Switzerland

Location status: Recruiting

Location contact

Clemens Haselmann, MD

SUB_INVESTIGATOR

Martin Schweiger, Prof, MD, MBA

CONTACT

[email protected]

+41 44 249 6511

Martin Schweiger, Prof, MD, MBA

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 30 day Mortality

    Time frame: 30 days after index operation

    Number of early deaths (30 days post surgery)

  2. Overall Length of Stay

    Time frame: 30 days after index operation

    Time between operation and discharge from hospital

  3. Length of intubation

    Time frame: 30 days after index operation

    Days necessary to wean patient from mechanical ventilatory support post surgery.

  4. Length of Stay on ICU

    Time frame: 30 days after index operation

    Time between operation and discharge from the intensive care unit (ICU)

  5. Unplanned hospital re-admission

    Time frame: 30 days after index operation

    Binary outcome, if patients is re-admitted for a reason related to his surgical intervention to hospital after being discharged.

  6. Signs of upcoming heart failure, determined by cardiac echo

    Time frame: 30 days after index operation

    Echocardiographic signs of imminent heart failure

Study contacts

Contact information is provided by the study sponsor or research team.

Clemens Haselmann, MD

CONTACT

Martin Schweiger, Prof, MD, MBA

CONTACT

[email protected]

+41 44 249 6511

Sponsors and collaborators

Lead sponsor

Martin Schweiger

Other

Collaborators

  • University Children's Hospital, Zurich

Registry information

Official study title

Biomarker in Congenital Cardiac Surgery - sST2 Marker in Heart Failure in Congenital Heart Disease After Surgery Research and Translational Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jun 19, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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