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

C

CHU de Reims

Status

Completed

Conditions

Aortic Stenosis

Treatments

Radiation: HDP-Tc99m bone scintigraphy

Study type

Interventional

Funder types

Other

Identifiers

NCT05384418
PO20143

Details and patient eligibility

About

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.

Full description

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

Enrollment

103 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

103 participants in 1 patient group

patients undergoing transcatheter aortic valve implantation
Experimental group
Description:
patients undergoing transcatheter aortic valve implantation for aortic stenosis
Treatment:
Radiation: HDP-Tc99m bone scintigraphy

Trial contacts and locations

1

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Central trial contact

Jérôme COSTA

Data sourced from clinicaltrials.gov

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