Risk stratification strategy of patients with cardiac sarcoidosis

• Research type

  Research Study

• Full title

  The role of conventional and advanced imaging modalities in formulating an optimal risk stratification strategy in patients with suspected cardiac sarcoidosis

• IRAS ID

  310314

• Contact name

  Vasileios Kouranos

• Contact email

  V.Kouranos@rbht.nhs.uk

• Sponsor organisation

  Royal Brompton Hospital & Harefield Hospitals, Part of Guy's & St Thomas' NHS Foundation Trust

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  Primary objectives
  - To define the natural history of cardiac sarcoidosis
  - To develop a risk stratification strategy in patients with suspected and confirmed cardiac sarcoidosis.
  - To identify endpoints for use in future clinical trials

  Secondary Objectives
  1. To assess the diagnostic role of each imaging modality in isolation and after integration in multi-disciplinary meeting approach.
  2. To define the prognostic role of interventions such as immunosuppression, heart failure medications, and anti-arrhythmic agents in cardiac sarcoidosis
  3. To identify independent predictors of outcome in patients with cardiac sarcoidosis
  4. To compare subgroups of cardiac sarcoidosis patients: a) patients with known extra-cardiac disease, b) patients with not known extra-cardiac disease presenting with unexplained otherwise cardiac manifestations such as atrio-ventricular block (AVB), ventricular tachycardia (VT), new onset heart failure and extra-cardiac sarcoidosis is confirmed and c) isolated cardiac sarcoidosis regarding their original presentation, imaging patterns and outcome.
  5. To assess the demographic characteristics of isolated cardiac sarcoidosis and whether this entity’s disease behavior is different compared to patients with cardiac sarcoidosis with extra-cardiac biopsy proven confirmation
  6. To assess the role of echocardiography as screening tool in patients with suspected cardiac sarcoidosis
  7. To evaluate the effect of immunosuppressive treatment (different subtypes) in core features of patients with cardiac sarcoidosis such as LVEF and FDG PET scan appearances and correlate these changes with outcomes.
  8. To identify risk factors for complications in cardiac sarcoidosis patients requiring device implantation.
  9. To highlight predictors of arrhythmias in patients with cardiac sarcoidosis that do not fulfill the criteria for device implantation.
  10. To identify the potential role of ILR implantation in patients with cardiac sarcoidosis that do not fulfill the criteria for device implantation.
  11. To evaluate the role of comprehensive echocardiographic assessment in prognosis of patients with suspected cardiac sarcoidosis and those with confirmed cardiac involvement.

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  22/PR/0459

• Date of REC Opinion

  7 Apr 2022

• REC opinion

  Favourable Opinion