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

NCT05384418 | Completed

• 1 other identifier: PO20143
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Keywords

Cardiac amyloïdosis; aortic stenosis; transthyretine amyloïdosis; CA-TTR; transcatheter aortic valve implantation; TAVI; prevalence; outcome; survival

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

patients undergoing transcatheter aortic valve implantation

EXPERIMENTAL

patients undergoing transcatheter aortic valve implantation for aortic stenosis

Radiation: HDP-Tc99m bone scintigraphy

Interventions

HDP-Tc99m bone scintigraphy RADIATION

HDP-Tc99m bone scintigraphy

patients undergoing transcatheter aortic valve implantation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- AL amyloïdosis patients

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: May 20, 2022
• Study Start: December 9, 2020
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

FR (1)