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Completed

NCT Number: NCT01358513

Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis

The aortic valve is the main outlet valve from the heart. This valve can become diseased and narrowed when it needs to be replaced with an artificial valve. Currently, this is the commonest reason for someone to undergo a heart valve operation in the UK. Unfortunately, there are no medical treatments that can prevent or delay the progression of this disease process. Here, the investigators propose to use new state-of-the-art imaging techniques to better understand the disease process so that the investigators can effectively design and assess potential new treatments. The ultimate aim is to stop this disease before patients need to have surgery. In addition the investigators believe this technique will allow us to predict the rate of progression of the disease

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Calcinosis Calcium Metabolism Disorders Cardiovascular Diseases Heart Diseases Heart Valve Diseases Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Outflow Obstruction

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Cardiovascular Sciences, University of Edinburgh

Edinburgh, Scotland, EH16 4SE, United Kingdom

About this study

Aortic stenosis is the commonest valvular heart disease in the western world and is the leading indication for valve surgery. Histological studies have suggested similarities with atherosclerosis including inflammation, lipid deposition, increased macrophage activity and calcification. However, recent randomised controlled trials have failed to demonstrate a reduction in the rate of disease progression with statin therapy and the investigators believe there is now a need to re-evaluate the underlying factors involved in the initiation and progression of aortic stenosis. The investigators propose to assess the role of inflammation and calcification in the pathogenesis and progression of aortic stenosis by using positron emission tomography with [18F]-fluorodeoxyglucose and [18F-]-fluoride in patients with a range of aortic valve disease. The investigators hypothesise that increasing severity of valvular inflammation and calcification will correlate with disease severity and rate of disease progression. This work will lay the foundation for the subsequent application of interventions targeted at inflammation and calcification.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 50 years

Exclusion criteria

  • Age < 50 years
  • Life expectancy < 2 years
  • Insulin dependent diabetes mellitus
  • Connective Tissue disorders

Treatment and study plan

Primary outcomes

  1. Aortic Valve Peak Velocity

    Time frame: 2 years

    We beleive NaF and FDG uptake in the valve will predict rate of progression of the disease. Disease severity will be measured by the aortic valve peak velocity

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • British Heart Foundation
  • NHS Lothian

Registry information

Official study title

An Observational PET/CT Study Examining the Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
May 23, 2011
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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