Regression of Myocardial Fibrosis After Aortic Valve Replacement

NCT02174471 | Completed

• 1 other identifier: ReDA ID 07/0166
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

Brief Summary

Aortic stenosis (AS) is the most common valvular heart condition in the United Kingdom and the Western world. Surgery for severe AS prior to symptom onset is controversial. Conventionally changes in valve area and gradient are used to time intervention but myocardial changes may be more predictive of surgical need. This study aims to elucidate the role of diffuse myocardial fibrosis as a prognostic marker, implementing a novel, non-invasive MRI technique to measure it. Design: The investigators will measure diffuse myocardial fibrosis in 150 patients with severe narrowing of the aortic valve before and one year after valve replacement. Expected outcomes: Diffuse myocardial fibrosis measured by MRI scanning will predict outcome after surgery in aortic stenosis. Anticipated Health Benefits: Identify patients with higher post operative morbidity and mortality, who may benefit from earlier valve replacement.

Conditions

Aortic Stenosis

Keywords

Aortic Stenosis; Aortic Valve Replacement; T1 Mapping; Extracellular Volume Fraction; Cardiovascular Magnetic Resonance; Diffuse Myocardial Fibrosis

Outcome Measures

Primary Outcomes (2)

• Cardiovascular death

  12 months

• Major adverse cardiovascular events (MACE)

  MACE: hospitalisation with heart failure, chest pain, syncope, arrhythmia or stroke

  12 months

Secondary Outcomes (2)

• Functional improvement

  12 months

• Regression of diffuse myocardial fibrosis

  12 months

Other Outcomes (1)

• LV remodeling post AVR

  12 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe aortic stenosis awaiting valve replacement recruited from cardiology outpatient department or as cardiology inpatients.

You may qualify if:

• Severe aortic stenosis (1 or more of: aortic valve area \< 1.0cm2, peak pressure gradient \>64mmHg, or mean pressure gradient \> 40mmHg).
• Symptomatic.
• Age \> 18 years and \< 90 years.

You may not qualify if:

• Severe valvular disease other than AS.
• Previous Valve surgery
• Severe renal impairment eGFR \< 30ml/min.
• Any absolute contraindication to CMR
• Other medical condition that limits life expectancy or precludes AVR.
• Pregnancy

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

The Heart Hospital, University College London Hospitals

London, W1G 8PH, United Kingdom

Location

Related Publications (6)

• Flett AS, Hayward MP, Ashworth MT, Hansen MS, Taylor AM, Elliott PM, McGregor C, Moon JC. Equilibrium contrast cardiovascular magnetic resonance for the measurement of diffuse myocardial fibrosis: preliminary validation in humans. Circulation. 2010 Jul 13;122(2):138-44. doi: 10.1161/CIRCULATIONAHA.109.930636. Epub 2010 Jun 28.

  PMID: 20585010 BACKGROUND

• Flett AS, Sado DM, Quarta G, Mirabel M, Pellerin D, Herrey AS, Hausenloy DJ, Ariti C, Yap J, Kolvekar S, Taylor AM, Moon JC. Diffuse myocardial fibrosis in severe aortic stenosis: an equilibrium contrast cardiovascular magnetic resonance study. Eur Heart J Cardiovasc Imaging. 2012 Oct;13(10):819-26. doi: 10.1093/ehjci/jes102. Epub 2012 May 25.

  PMID: 22634740 BACKGROUND

• Bhuva AN, Treibel TA, De Marvao A, Biffi C, Dawes TJW, Doumou G, Bai W, Patel K, Boubertakh R, Rueckert D, O'Regan DP, Hughes AD, Moon JC, Manisty CH. Sex and regional differences in myocardial plasticity in aortic stenosis are revealed by 3D model machine learning. Eur Heart J Cardiovasc Imaging. 2020 Apr 1;21(4):417-427. doi: 10.1093/ehjci/jez166.

  PMID: 31280289 DERIVED

• Smith A, Moravcova S, Treibel TA, Colque-Navarro P, Mollby R, Moon JC, Hamilton-Davies C. Relationship between endotoxin core, staphylococcal and varicella antibody levels and outcome following aortic valve replacement surgery: a prospective observational study. Perioper Med (Lond). 2018 Sep 20;7:20. doi: 10.1186/s13741-018-0101-z. eCollection 2018.

  PMID: 30250733 DERIVED

• Treibel TA, Kozor R, Schofield R, Benedetti G, Fontana M, Bhuva AN, Sheikh A, Lopez B, Gonzalez A, Manisty C, Lloyd G, Kellman P, Diez J, Moon JC. Reverse Myocardial Remodeling Following Valve Replacement in Patients With Aortic Stenosis. J Am Coll Cardiol. 2018 Feb 27;71(8):860-871. doi: 10.1016/j.jacc.2017.12.035.

  PMID: 29471937 DERIVED

• Treibel TA, Kozor R, Fontana M, Torlasco C, Reant P, Badiani S, Espinoza M, Yap J, Diez J, Hughes AD, Lloyd G, Moon JC. Sex Dimorphism in the Myocardial Response to Aortic Stenosis. JACC Cardiovasc Imaging. 2018 Jul;11(7):962-973. doi: 10.1016/j.jcmg.2017.08.025. Epub 2017 Nov 15.

  PMID: 29153564 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and Plasma; myocardial biopsy obtained intra-operatively.

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• James C Moon, MD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 25, 2014
• Study Start: October 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: June 3, 2016

Record last verified: 2015-05

Locations

GB (1)