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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06060171
Acronym
PATH-VHD
Enrollment
360
Registered
2023-09-29
Start date
2021-08-01
Completion date
2025-01-01
Last updated
2023-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular Heart Disease

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.

Interventions

Surgical or transcatheter aortic valve intervention

Sponsors

British Heart Foundation
CollaboratorOTHER
Horizon 2020 - European Commission
CollaboratorOTHER
University College, London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Multisystem study: Correlation between capillary density and stress myocardial blood flow in severe valve disease before intervention (at baseline)Single timepoint
Multisystem study: Correlation between brain blood flow (arterial spin labelling) and stress myocardial blood flow in severe valve disease before intervention (at baseline)Single timepoint
Intervention study: Change in stress myocardial blood flow from baseline to 6 months after aortic valve replacementBaseline and 6 months after surgery
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 replacementBaseline and 6 months after surgery

Countries

United Kingdom

Contacts

Primary ContactGeorge D Thornton, MD
george.thornton@ucl.ac.uk+4420 3465 5543
Backup ContactThomas Treibel, MD PhD
thomas.treibel.12@ucl.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026