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

Aortic Stenosis Clinical Trial

— CAMPOS-TAVI  

Official title:

Cardiac AMyloidosis Prevalence and Outcome in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation (CAMPOS-TAVI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05384418
• Other study ID #: PO20143
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2020
• Est. completion date: December 9, 2022

Study information

• Verified date: August 2021
• Source: CHU de Reims
• Contact: Jérôme COSTA
• Phone: 03 10 73 63 14
• Email: jcosta[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

inclusion criteria :

• patients over 60 years old

• Patients admitted in Reims university cardiology department for per-cutaneous aortic valve replacement due to severe aortic stenosis

• Patients enrolled in the national healthcare insurance program

• Patients consenting to participate to the study

exclusion criteria :

• AL amyloïdosis patients

Related Conditions & MeSH terms

• Amyloidosis
• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Radiation:
• HDP-Tc99m bone scintigraphy
HDP-Tc99m bone scintigraphy

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transthyretine cardiac amyloïdosis	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).	Hour 3