Pathological Changes in the Cardiovascular System in Valvular Heart Disease

Valvular Heart Disease Clinical Trial

— PATH-VHD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06060171
• Other study ID #: 134018
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: September 2023
• Source: University College, London
• Contact: George D Thornton, MD
• Phone: +4420 3465 5543
• Email: george.thornton[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Procedure:
• Aortic valve intervention
Surgical or transcatheter aortic valve intervention

Locations

Country	Name	City	State
United Kingdom	Barts Heart Centre	London

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	British Heart Foundation, Horizon 2020 - European Commission

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multisystem study: Correlation between capillary density and stress myocardial blood flow in severe valve disease before intervention (at baseline)		Single timepoint
Primary	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
Primary	Intervention study: Change in stress myocardial blood flow from baseline to 6 months after aortic valve replacement		Baseline and 6 months after surgery
Primary	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		Baseline and 6 months after surgery