Clinical trial NCT06060171: Pathological Changes in the Cardiovascular System in Valvular Heart Disease
Official title: Pathological Changes in the Cardiovascular System in Valvular Heart Disease: Validation of Non-invasive Markers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Valvular Heart Disease
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: Horizon 2020 - European Commission
First posted: 2023-09-29
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Natural history cohort: Patients with three common valvular lesions: Aortic stenosis, aortic regurgitation and mitral regurgitation

Multisystem impact of valvular heart disease: Patients with severe symptomatic valvular heart disease referred for surgery

Response to intervention: Patients with severe symptomatic valvular heart disease undergoing intervention

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.


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.

Primary outcomes:
measure: Multisystem study: Correlation between capillary density and stress myocardial blood flow in severe valve disease before intervention (at baseline)
timeFrame: Single timepoint
measure: Multisystem study: Correlation between brain blood flow (arterial spin labelling) and stress myocardial blood flow in severe valve disease before intervention (at baseline)
timeFrame: Single timepoint
measure: Intervention study: Change in stress myocardial blood flow from baseline to 6 months after aortic valve replacement
timeFrame: Baseline and 6 months after surgery
measure: 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
timeFrame: Baseline and 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Heart Centre
Study officials:
References: