Paediatric cardiological research
Project description: Clinical Observational and Interventional Study to Prevent the Occurence of Post Intensive Care Syndrome in Critically Ill Children and their Families
Prospective multicentre study at four paediatric intensive care units in Baden-Württemberg. The aim of the project is to prove the superiority of a new form of care for the treatment of critically ill children in the intensive care unit by an interprofessional team. The new form of care is characterised by six so-called bundles (ABCDEF): (A) Implementation of care-controlled analgosedation protocols. (B) Establishment of a ventilation and weaning protocol. (C) Reduction of sedation (D) Early detection of delirium and withdrawal with standardised scores. (E) Early mobilisation. (F) Involvement of parents / family-centred intensive care.
Responsible investigator: Dr. med. René Höhn (ORCID)
Project description: COMPERA/COMPERA-KIDS (Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension)
German and European pulmonary hypertension registry, established in 2007 and including patients with all forms of PH if drug therapy is indicated. The registry observes initial and long term therapy as well as the long term course of patients with PH. Observational Study, no study interventions.
Responsible investigator: Prof. Dr. med. Brigitte Stiller (ORCID)
Project description: A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension.
Responsible investigator: Prof. Dr. med. Brigitte Stiller (ORCID)
Project description: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged ≥2 to <18 years with Pulmonary Arterial Hypertension.
Responsible investigator: Prof. Dr. med. Brigitte Stiller (ORCID)
Project description: Personalised diagnostics using MRI and testing of cell free donor DNA concentration during the first year after heart transplantation.
Responsible investigator: Prof. Dr. med. Brigitte Stiller (ORCID)
Project description: Prospective multi-center registry for children and adolescents with myocarditis. The aim is to generate prospective multi-center data on epidemiology, diagnostics, and therapy of pediatric patients with myocarditis in order to enable evidence-based diagnostic and therapeutic approaches for this myocardial disease.
Responsible investigator: Prof. Dr. med. Brigitte Stiller (ORCID)
Project description: Multicenter Clinical Study in Accordance with §47 (3) MPDG to Evaluate Efficacy and Safety of the GORE® CARDIOFORM ASD Occluder for Transcatheter Closure in Patients with Atrial Septal Defects (ASD II).
Responsible investigator: Prof. Dr. med. Brigitte Stiller (ORCID)
Project description: A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
Responsible investigator: PD Dr. med. Rouven Kubicki (ORCID)
Project description: A Phase 2/3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants with Heart Failure due to Systemic Left Ventricular Systolic Dysfunction.
Responsible investigator: Prof. Dr. med. Brigitte Stiller (ORCID)
Project description: As a collaborative project between IEKM and the Deparment of Congenital Heart Disease and Pediatric Cardiology, we investigate the effect of different congenital heart defects and their hemodynamic impairments (e.g. volume overload, pressure overload, outflow tract obstructions) on the structure and function of cardiomyocytes, non-cardiomyocytes, and extracellular matrix in the heart, as well as on extracardiac immune cells in the peripheral blood.
Responsible investigators: Alex Klesen (ORCID), Hannah Kappler (ORCID)