The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Edinburgh
Sponsor:
Collaborator:
British Heart Foundation
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01755936
First received: December 19, 2012
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

Aortic stenosis is the most common adult valvular heart disease in the western world. Heart failure and sudden cardiac death are complications associated with aortic stenosis. In symptomatic individuals, valve replacement is often the only effective treatment. However, there are no good markers to identify patients who may benefit from early surgery before symptoms developed. The purpose of the study is to test the hypothesis that the presence heart muscle scarring on the cardiac magnetic resonance imaging may predict a worse outcome in patients with aortic stenosis, and thus may be helpful in identifying patients for early valve replacement.


Condition Intervention
Aortic Stenosis
Other: Cardiac Magnetic Resonance Imaging
Other: Echocardiography
Other: 72 hour Holter Monitor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Cardiovascular events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Cardiovascular events defined as cardiovascular deaths, development of heart failure symptoms, and the need for aortic valve replacement.


Biospecimen Retention:   Samples Without DNA

Full blood count and renal panel will be measured.


Estimated Enrollment: 240
Study Start Date: January 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Controls
Patients will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring
Other: Cardiac Magnetic Resonance Imaging
For the evaluation of left ventricular volumes, function and mass. Also for the assessment of myocardial fibrosis based on the presence of delayed enhancement. Novel application of T1 mapping techniques will be evaluated.
Other: Echocardiography
Assessment of aortic stenosis severity. Also evaluate diastolic and systolic function.
Other: 72 hour Holter Monitor
This will enable us to detect abnormal heart rhythms which may be associated with myocardial fibrosis
Aortic Stenosis patients
All patients who agreed to study will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring
Other: Cardiac Magnetic Resonance Imaging
For the evaluation of left ventricular volumes, function and mass. Also for the assessment of myocardial fibrosis based on the presence of delayed enhancement. Novel application of T1 mapping techniques will be evaluated.
Other: Echocardiography
Assessment of aortic stenosis severity. Also evaluate diastolic and systolic function.
Other: 72 hour Holter Monitor
This will enable us to detect abnormal heart rhythms which may be associated with myocardial fibrosis

Detailed Description:

Congestive heart failure and sudden cardiac death are associated complications of aortic stenosis. Currently, the indications for valvular replacement are based on the valvular severity evaluated by echocardiography and the presence of symptoms. There is some evidence to suggest the presence of myocardial fibrosis is associated with a poor outcome in patients with aortic stenosis. The aim of this prospective study is to investigate the prognostic implications of myocardial fibrosis in patients with aortic stenosis. The presence of myocardial fibrosis will be identified by delayed enhancement with the cardiac magnetic resonance imaging at 3T. We will also be evaluating the application of T1 mapping techniques to detect diffuse myocardial fibrosis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

A total of 240 individuals will be recruited. This includes 48 individuals who do not have aortic stenosis. A total of 192 individuals with aortic stenosis will be recruited:

  1. Mild aortic stenosis, n=48
  2. Moderate aortic stenosis, n=48
  3. Severe aortic stenosis, n=48
  4. Symptomatic aortic stenosis with planned valve replacement, n=48
Criteria

Inclusion Criteria:

  • Patients with aortic stenosis
  • Willing to undergo all investigations

Exclusion Criteria:

  • Coexisting mitral valvular heart disease and aortic regurgitation (more than moderate severity)
  • Active medical conditions: ongoing heart failure, infection
  • Significant comorbidities: advanced malignancy with limited life expectancy
  • Unable to give informed consent
  • Contraindication for cardiac magnetic resonance imaging: impaired renal function, pacemaker, claustrophobia
  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: NCT01755936

Contacts
Contact: Calvin Chin, MD 0131 242 6422 cchin03m@gmail.com

Locations
United Kingdom
University of Edinburgh Recruiting
Edinburgh, Midlothian, United Kingdom, EH16 4SB
Contact: Calvin Chin, MD    0131 242 6422    cchin03m@gmail.com   
Sponsors and Collaborators
University of Edinburgh
British Heart Foundation
Investigators
Principal Investigator: David E Newby, MD PhD University of Edinburgh
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01755936     History of Changes
Other Study ID Numbers: 2010/R/CAR/05
Study First Received: December 19, 2012
Last Updated: January 15, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Edinburgh:
Aortic Stenosis
Cardiac magnetic resonance imaging
Late Gadolinium enhancement
T1 mapping techniques
Replacement fibrosis
Diffuse interstitial fibrosis

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Fibrosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014