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

U

University of Edinburgh

Status

Completed

Conditions

Aortic Stenosis

Study type

Observational

Funder types

Other

Identifiers

NCT01358513
RING OF FIRE

Details and patient eligibility

About

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

Full description

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.

Enrollment

121 patients

Sex

All

Ages

50 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age > 50 years

Exclusion criteria

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

Trial design

121 participants in 5 patient groups

Control Patients
Description:
Patients with normal aortic valves
Aortic sclerosis
Description:
To undergo PET imaging and follow up with CT and echo for 2 years
Mild Aortic stenosis
Description:
To undergo PET imaging and follow up with CT and echo for 2 years
Moderate Aortic stenosis
Description:
To undergo PET imaging and follow up with CT and echo for 2 years
Severe aortic stenosis
Description:
To undergo PET imaging and follow up with CT and echo for 2 years

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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