Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)

Aortic Bioprosthesis Structural Valve Dysfunction Clinical Trial

— TEP-SVD  

Official title:

Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015818
• Other study ID #: RC16_0137
• Status: Completed
• Phase: Phase 4
• Start date: January 30, 2017
• Est. completion date: May 3, 2019

Study information

• Verified date: January 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Structural valve dysfunction (SVD) is the most common and life threatening complication in patients treated by aortic valve replacement. A calcification process is frequently involved in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic phenomenon of calcification, as previously shown in native aortic valve stenosis, rather than a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging with 18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue.

This study will include patients with echocardiography-confirmed SVD. Echocardiographic parameters and other current parameters analyzed in SVD patients such as bioprosthesis calcium scoring derived from CT will be compared to 18F-Fluoride activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 3, 2019
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18

• written informed consent

• SVD defined on echocardiography by an alteration of bioprosthesis leaflets function with a mean transvalvular gradient > 20 mmHg and maximal velocity = 3 m/s and effective orifice area =1.2 cm², and/or an aortic regurgitation more or equal to grade 2 on 4.

Exclusion Criteria:

• Inability to give informed consent

• Pregnancy

• Concurrent antibiotherapy

• Certain infectious endocarditis

• Concurrent anti-inflammatory therapy, including corticosteroid therapy

Related Conditions & MeSH terms

• Aortic Bioprosthesis Structural Valve Dysfunction

Intervention

Other:
• 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT
18F-Fluoride PET-CT CT calcium scoring 18F-FDG PET-CT

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	18F-Fluoride activity	18F-Fluoride activity in valvular tissue will be determined by a tissue to bloodpool ratio of SUV (TBR). Patients will be divided in two groups : moderate SVD (EOA = 0.8 and = 1.2 cm²), and severe SVD (EOA = 0.8 cm²), and TBR will be compared between the two groups, determined at time of inclusion.	The day of the inclusion
Secondary	TBR in 18F-FDG	TBR in 18F-FDG will be compared between the two groups to analyze the inflammatory activity part in the SVD process	6 months
Secondary	Both 18F-Fluoride and 18F-FDG TBR correlation	Both 18F-Fluoride and 18F-FDG TBR will be correlated with bioprosthesis calcium scoring and the following echocardiographic bioprosthesis function parameters : aortic regurgitation grade (none, trace, mild, moderate, severe) ; trans-valvular maximal velocity (m/s) ; mean trans-valvular gradient (mm Hg) ; EOA (cm²) ; visual echographic degenerescence score.	6 months