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临床试验/NCT06060171
NCT06060171招募中不适用

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

University College, London1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
360
试验地点
1
主要终点
Multisystem study: Correlation between capillary density and stress myocardial blood flow in severe valve disease before intervention (at baseline)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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

时间窗: 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)

时间窗: Single timepoint

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

时间窗: Baseline and 6 months after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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