Pathological Changes in the Cardiovascular System in Valvular Heart Disease (PATH-VHD)

University College London (UCL)

Status: Enrolling

Conditions: Valvular Heart Disease

Treatments: Procedure: Aortic valve intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06060171

134018

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

360 participants in 3 patient groups

Natural history

Description:

Natural history of the three common valvular lesions; aortic stenosis, aortic regurgitation and mitral regurgitation. Patients with mild, moderate and severe valvular heart disease (VHD) will be followed up at 1-year to measure progression in remodelling (hypertrophy, ischaemic, scar).

Multisystem impact of VHD

Description:

Patients with severe symptomatic VHD will undergo non-invasive brain and cardiac magnetic resonance imaging (MRI) plus other non-invasive imaging tests to quantify small blood vessels across the cardiovascular system at baseline and at 6 months after surgical aortic valve replacement at which point a myocardial biopsy is taken.

Treatment:

Procedure: Aortic valve intervention

Response to intervention.

Description:

Patients with severe symptomatic VHD undergoing intervention will be followed up at 6 months to assess reverse remodelling after valve intervention. In those undergoing open-heart surgery, a myocardial biopsy will be taken to validate and complement non-invasive imaging.

Treatment:

Procedure: Aortic valve intervention