Scandinavian trial of Uncomplicated Aortic Dissection Therapy (SUNDAY Trial)

Study design

Randomized controlled trial.

About the project

Objective(s)

Primary objective for the SUNDAY Trial.

To compare the overall survival at five years between subjects treated with Standard Medical Therapy(SMT) and SMT + TEVAR

Secondary objectives.

To compare the risk of aortic-related mortality

To compare the risk of neurological injury, including stroke or paraplegia

To compare the proportion and indication of subjects who underwent an aortic intervention within 5 years due to development of an aortic complication

To compare the numbrér of disease-related readmissions during follow-up

To compare , based on subgroup analysis, whether extent of TEVAR is associated with either improved survival or neurological injury

To compare the asssociated risk of reinterventions, including those subjects who were initially randomized to SMT and subsequently required an arortic intervention

To compare the associated changes in quality-of-life

To compare the 10-year overall survival and aortic-related mortality

To compare the cost.

International collaborators and advisory board

  • NM Rahman, EO Bedawi
    NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK
  • B Naidu
    Department of Thoracic Surgery, Queen Elizabeth Hospital Birmingham, UK & Institute of Inflammation and Ageing, University of Birmingham, UK

Monitoring committee

  • J Davidsen
    Department of Respiratory Medicine, Odense University Hospital
  • M Stenger
    Department of Cardiothoracic and Vascular Surgery, Odense University Hospital

Collaboration

Participating centres

  • Department of Cardio-thoracic Surgery, Rigshospitalet, Copenhagen University Hospital
  • Department of Cardiothoracic and Vascular Surgery, Odense University Hospital
  • Department of Cardiothoracic Surgery, Aalborg University Hospital
  • Department of Respiratory Medicine, Odense University Hospital
  • Department of Respiratory Medicine, Aarhus University Hospital
  • Department of Respiratory Medicine, Herlev-Gentofte Hospital, Copenhagen University Hospital
  • Department of Respiratory Medicine, Aalborg University Hospital
  • Department of Respiratory Medicine, Holstebro Hospital
  • Department of Respiratory Medicine, Viborg-Skive Hospital
  • Department of Respiratory Medicine, Horsens Hospital
  • Department of Respiratory Medicine, Randers Hospital
  • Department of Respiratory Medicine, Lillebaelt Hospital, Kolding
  • Department of Acute Medicine, Aabenrå Hospital
  • Department of Respiratory Medicine, Esbjerg Hospital
  • Department of Respiratory Medicine, Naestved-Slagelse Hospital
  • Department of Acute Medicine, Odense University Hospital
  • Department of Radiology, Aarhus University Hospital
  • Department of Radiology, Odense University Hospital

Funding

This work was supported by the Novo Nordisk Foundation (grant no.: 0065455) and Skibsreder Per Henriksen, R. og Hustrus Fond.

Published papers

Status

Ongoing

Project period

Start: 1. of April 2023 
End: 30 th. of September 2028

Contact

Principal investigator

Jacob Budtz-Lilly

Clinical Associate Professor