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

Phase 4

Completed

• Conditions: Aortic Bioprosthesis Structural Valve Dysfunction
• Interventions: Other: 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT

• Registration Number: NCT03015818
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-10
• Study Start: 2017-01-30
• Primary Completion: 2019-05-03
• Study Completion: 2019-05-03
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

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Exclusion Criteria

• Inability to give informed consent
• Pregnancy
• Concurrent antibiotherapy
• Certain infectious endocarditis
• Concurrent anti-inflammatory therapy, including corticosteroid therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT	18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT	-

Primary Outcome Measures

Name	Time	Method
18F-Fluoride activity	The day of the inclusion	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.

Secondary Outcome Measures

Name	Time	Method
Both 18F-Fluoride and 18F-FDG TBR correlation	6 months	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.
TBR in 18F-FDG	6 months	TBR in 18F-FDG will be compared between the two groups to analyze the inflammatory activity part in the SVD process

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France