Cardiac Amyloidosis Prevalence and Outcome in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation

Not Applicable

• Conditions: Aortic Stenosis
• Interventions: Radiation: HDP-Tc99m bone scintigraphy

• Registration Number: NCT05384418
• Lead Sponsor: CHU de Reims

Brief Summary

Aortic stenosis (AS) is the most frequent valvulopathy in the general population in France and more generally in developed countries, due to populations aging. Its standard treatment is historically surgical aortic valve replacement (SAVR). In the 2000s, the management of this valvulopathy was revolutionized by the development of the technique of per-cutaneous aortic valve replacement (TAVI). TAVI opens the possibility of curative treatment to patients at high operational risk not operable by conventional surgery, and for whom outcome was affected with high mortality under medical treatment alone.

Amyloidosis, a pathology with multiple etiologies, is a rare condition and its cardiac form (AC) even more (8 to 17 / 100,000 people / year). However, its prevalence is increasing. Some autopsies series have found prevalence up to 50% of cardiac amyloidosis with transthyretin (AC-TTR) after 60 years. In addition, recent data suggested that AC-TTR prevalence is higher in the population of patients with heart disease: 13% in heart failure with preserved ejection fraction and up to 16% in patients with AS. The outcome of patients with AC-TTR remains unknown after TAVI. Thus, the diagnosis of AC-TTR in patients undergoing TAVI represents an important issue. Indeed, a treatment stabilizing the process of accumulation of transthyretin deposits, effective on the survival of these patients, is now available. In addition, a non-invasive screening strategy for AC-TTR, alternative to biopsy, is now validated.

Detailed Description

The aim of the study is to describe prevalence of cardiac amyloidosis with transthyretin in patients undergoing transcatheter aortic valve implantation.

Study Timeline

• Study First Submitted: 2020-11-20
• Study Start: 2020-12-09
• Status Verified: 2021-08
• Primary Completion: 2021-12-09
• Study First Submitted QC: 2022-05-19
• Last Update Submitted: 2022-05-19
• Study First Posted: 2022-05-20
• Last Update Posted: 2022-05-20
• Study Completion: 2022-12-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients undergoing transcatheter aortic valve implantation	HDP-Tc99m bone scintigraphy	patients undergoing transcatheter aortic valve implantation for aortic stenosis

Primary Outcome Measures

Name	Time	Method
transthyretine cardiac amyloïdosis	Hour 3	Transthyretine cardiac amyloïdosis will be diagnosed using HDP-99mTc bone scintigraphy.; The examination will consist of the injection of 10 MBq / kg of 99mTc-labeled biphosphonate, followed by a full-body scan 3 hours post-injection to produce a front thoracic static image and a tomographic image of the thorax.; A positive HDP-Tc99m bone scintigraphy will be defined according to the Perugini classification corresponding to stages 2 and 3 (myocardial fixation of intensity equal to or greater than the bone structures).

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France