Cardiac Amyloidosis in Patients With Aortic Stenosis

Fudan University

Status

Not yet enrolling

Conditions

Transthyretin Amyloid Cardiomyopathy

Aortic Stenosis

Treatments

Procedure: transcatheter aortic valve replacement (TAVR)

Study type

Observational

Funder types

Other

Identifiers

NCT07170306

CA-TAVR

Details and patient eligibility

About

This study intends to conduct a prospective observation to investigate the prevalence of cardiac amyloidosis (CA) in patients with aortic stenosis (AS), compare the clinical characteristics between patients with isolated AS and those with AS complicated by CA (CA-AS), and simultaneously explore the impact of transcatheter aortic valve replacement (TAVR) on serum transthyretin (TTR) levels in patients with AS complicated by transthyretin amyloidosis (ATTR-AS), as well as its influence on the treatment outcomes of patients with isolated AS and ATTR-AS.

Full description

Amyloid infiltration involving the aortic valve may cause endothelial damage, which in turn accelerates calcification and leads to the development or exacerbation of aortic stenosis (AS). Previous studies have shown that the comorbidity rate of transthyretin amyloid cardiomyopathy (ATTR-CA) and AS ranges from 4.9% to 16%, and this rate is particularly notable in patients who have undergone transcatheter aortic valve replacement (TAVR).

Currently, although small-scale studies have explored the prognosis of patients with AS complicated by CA, some conclusions are contradictory and have limitations. The present study intends to conduct a prospective observational study: on one hand, to investigate the prevalence of CA in patients with AS and compare the clinical characteristics between patients with isolated AS and those with CA-complicated AS (CA-AS); on the other hand, to explore the impact of TAVR on serum transthyretin (TTR) levels in patients with ATTR-complicated AS (ATTR-AS), as well as its influence on the treatment outcomes of patients with isolated AS and ATTR-AS.

Enrollment

143 estimated patients

Sex

All

Ages

65 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients aged ≥ 65 years and ≤ 85 years;
Patients with moderate-to-severe degenerative aortic stenosis (AS) who are hospitalized and scheduled to undergo transcatheter aortic valve replacement (TAVR);
Patients who voluntarily sign the Informed Consent Form (ICF) and are able to comply with the study-specified treatment plan, follow-up visits, laboratory tests, and other requirements.

Exclusion criteria

Aortic stenosis (AS) caused by congenital diseases or rheumatic immune diseases;
Severe renal impairment, chronic dialysis, or unresolved acute kidney injury after transcatheter aortic valve replacement (TAVR);
Terminal-stage diseases with an expected life span of < 6 months;
Participation in other ongoing investigational studies of drugs or medical devices that have not yet been completed;
Patients who are unable to attend the follow-up visits scheduled in the study;
Failure to undergo TAVR surgery, transfer to surgical treatment, or in-hospital death.