NCT06060171

Pathological Changes in the Cardiovascular System in Valvular Heart Disease

Pathological Changes in the Cardiovascular System in Valvular Heart Disease: Validation of Non-invasive Markers

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 360 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An observational cohort study of patients recruited presenting with valvular heart disease. The specialized investigations will focus on myocardial remodelling and scar formation/regression and extracardiac micro- and macro-vascular sequelae of valvular heart disease (VHD). The aim is to investigate the natural history of VHD and its ensuing cardiac and extracardiac end organ effects, the impact of existing interventions and the long-term outcome. We hope to establish the underlying causative aetiology of known associated conditions (e.g. vascular dementia) and to determine if extracardiac changes may serve as early biomarkers of prognosis in VHD. Participants will attend for two visits at Barts Heart Centre or Chenies Mews Imaging Centre and will undergo a panel of tests including cross-sectional cardiac imaging, point-of-care microvascular assessment and blood tests. Patient outcome will be assessed by data linkage to hospital episode statistic (HES) data and ONS data (via NHS spine). We aim to identify determinants that will help to improve patient selection and timing of valve intervention based on advanced clinical, blood and/or imaging biomarkers.

Conditions

• Valvular Heart Disease

Interventions

Type	Name	Description
PROCEDURE	Aortic valve intervention	Surgical or transcatheter aortic valve intervention

Timeline

• Start date: 2021-08-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2023-09-29
• Last updated: 2023-10-06

Locations

1 site across 1 country: United Kingdom