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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Edinburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
NHS Lothian
British Heart Foundation
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01358513
First received: May 19, 2011
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

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


Condition
Aortic Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational PET/CT Study Examining the Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Aortic Valve Peak Velocity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples With DNA

In patients undergoing aortic valve replacement during the course of the trial we will retain samples of their aortic valve for histological studies.


Estimated Enrollment: 168
Study Start Date: July 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control Patients
Patients with normal aortic valves
Aortic sclerosis
Mild Aortic stenosis
Moderate Aortic stenosis
Severe aortic stenosis

Detailed 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The investigators will recruit 168 patients: 24 control patients, 24 mild, 48 moderate and 48 severe aortic stenosis

Criteria

Inclusion Criteria:

  • Age > 50 years

Exclusion Criteria:

  • Age < 50 years
  • Life expectancy < 2 years
  • Insulin dependent diabetes mellitus
  • Connective Tissue disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358513

Contacts
Contact: Marc Dweck, MBChB BSc 0131 242 6422 marcdweck@hotmail.com
Contact: David Newby, MBChB PhD 0131 242 6422 D.E.NEWBY@ED.AC.UK

Locations
United Kingdom
Centre for Cardiovascular Sciences, University of Edinburgh Recruiting
Edinburgh, Scotland, United Kingdom, EH16 4SE
Contact: Marc Dweck, MBChB BSc    0131 242 6422    marcdweck@hotmail.com   
Principal Investigator: David Newby, MBChB PhD         
Sub-Investigator: Marc Dweck, MBChB BSc         
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
British Heart Foundation
  More Information

No publications provided by University of Edinburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gemma Watson, University of Edinburgh
ClinicalTrials.gov Identifier: NCT01358513     History of Changes
Other Study ID Numbers: RING OF FIRE
Study First Received: May 19, 2011
Last Updated: May 20, 2011
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by University of Edinburgh:
Positron Emission Tomography
Inflammation
Calcification

Additional relevant MeSH terms:
Inflammation
Constriction, Pathologic
Calcinosis
Aortic Valve Stenosis
Pathologic Processes
Pathological Conditions, Anatomical
Calcium Metabolism Disorders
Metabolic Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 18, 2014