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Clinical Trials/NCT06060171
NCT06060171
Recruiting
Not Applicable

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

University College, London1 site in 1 country360 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Valvular Heart Disease
Sponsor
University College, London
Enrollment
360
Locations
1
Primary Endpoint
Multisystem study: Correlation between capillary density and stress myocardial blood flow in severe valve disease before intervention (at baseline)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
January 1, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 years
  • Able to provide written informed consent
  • Mild, moderate or severe valvular heart disease (Natural history cohort), or severe valvular heart disease planned for surgical/transcatheter intervention (Intervention/Heart-Brain axis cohort).

Exclusion Criteria

  • Participants unwilling to consent.
  • Needle phobic patients that would preclude blood taking
  • Diagnosis of dilated or hypertrophic cardiomyopathy
  • Pregnancy/breast feeding
  • Inability to complete the protocol, other conditions that would prevent participation in the study.
  • In severe VHD, no more than moderate valve disease other than primary lesion (AS / MR / AR)
  • Exclusion for the Heart-Brain-Axis Study:
  • Participants that have more than moderate epicardial coronary disease (by CT or invasive coronary angiography) will be excluded.

Outcomes

Primary Outcomes

Multisystem study: Correlation between capillary density and stress myocardial blood flow in severe valve disease before intervention (at baseline)

Time Frame: Single timepoint

Intervention study: Correlation between functional capacity, measured by cardiopulmonary exercise testing and myocardial blood flow and fibrosis by cardiovascular magnetic resonance and histology at baseline and at 6 months after valve replacement

Time Frame: Baseline and 6 months after surgery

Multisystem study: Correlation between brain blood flow (arterial spin labelling) and stress myocardial blood flow in severe valve disease before intervention (at baseline)

Time Frame: Single timepoint

Intervention study: Change in stress myocardial blood flow from baseline to 6 months after aortic valve replacement

Time Frame: Baseline and 6 months after surgery

Study Sites (1)

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