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Идёт набор NCT07029230

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

— Наблюдательное Congenital Heart Surgery Congenital Heart Disease in Children Fontan Physiology

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Congenital Heart Surgery, Congenital Heart Disease in Children, Fontan Physiology. Базовые параметры: до 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Surrogates of Heart Failure [Срок оценки: 1 year post surgery]
Вторичные конечные точки (6)
  • 30 day Mortality [Срок оценки: 30 days after index operation]
  • Overall Length of Stay [Срок оценки: 30 days after index operation]
  • Length of intubation [Срок оценки: 30 days after index operation]
  • Length of Stay on ICU [Срок оценки: 30 days after index operation]
  • Unplanned hospital re-admission [Срок оценки: 30 days after index operation]
  • Signs of upcoming heart failure, determined by cardiac echo [Срок оценки: 30 days after index operation]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Швейцария · 1 центр
  • University Children's Hospital Zurirch — Zurich

Публикации

  • 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 32246937
  • 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 31648713
  • 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 37176577
  • 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 31290383
  • 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 28028009

Идентификаторы

NCT: NCT07029230 · BASEC 2024-01297 · FZK 2025-INV-007

Первоисточники (государственные реестры)

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