NCT07029230

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Sep 2025Jan 2029

First Submitted

Initial submission to the registry

May 21, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 10, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

2.3 years

First QC Date

May 21, 2025

Last Update Submit

November 14, 2025

Conditions

Congenital Heart SurgeryCongenital Heart Disease in ChildrenFontan Physiology

Keywords

biomarkersst2congenital heart surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • 30 day Mortality

    30 days after index operation

  • Overall Length of Stay

    30 days after index operation

  • Length of intubation

    30 days after index operation

  • Length of Stay on ICU

    30 days after index operation

  • Unplanned hospital re-admission

    30 days after index operation

  • +1 more secondary outcomes

Study Arms (1)

Patients planned for congenital cardiac surgery

Patients planned for congenital cardiac surgery

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients in defined age scheduled for congenital cardiac surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital Zurirch

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

Related Publications (5)

  • 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.

    PMID: 32246937BACKGROUND

  • 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.

    PMID: 31648713BACKGROUND

  • 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.

    PMID: 37176577BACKGROUND

  • 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.

    PMID: 31290383BACKGROUND

  • 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.

    PMID: 28028009BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

Study Officials

  • Martin Schweiger, Prof, MD, MBA

    University Children's Hospital, Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Schweiger, Prof, MD, MBA

CONTACT

+41 44 249 6511sst2@kispi.uzh.ch

Clemens Haselmann, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending Physician Congenital Cardiac Surgery

Study Record Dates

First Submitted

May 21, 2025

First Posted

June 19, 2025

Study Start

September 10, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

January 31, 2029

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)