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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-10

Study Completion Date

2029-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Soluble ST2 and Cardiovascular Outcome

NCT04460131

Cardiovascular Disease

RECRUITING

Oxidative Stress Markers and Cardiac Resynchronization Therapy (CRT) Outcomes

NCT01151553

Congestive Heart Failure

TERMINATED NA

Impact of Donor and Recipient ST2 / IL-33 Pathway After Heart Transplantation

NCT03050892

Heart Transplant Failure and Rejection

UNKNOWN

New Biomarkers in Heart- and Renal Failure

NCT02830464

Heart Failure Kidney Failure

COMPLETED

Transpulmonary Gradient After Cardiac Surgery Under Cardiopulmonary Bypass

NCT01723930

Acute Respiratory Distress Syndrome After Cardiac Surgery Under Cardiopulmonary Bypass

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Heart Surgery Congenital Heart Disease in Children Fontan Physiology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients planned for congenital cardiac surgery

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No