Cardiac Amyloidosis in Patients With Aortic Stenosis

NCT ID: NCT07170306

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 143 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-05-31

Brief Summary

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.

Detailed 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.

Conditions

Aortic Stenosis; Transthyretin Amyloid Cardiomyopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ATTR-AS group

Patients were grouped according to the presence or absence of ATTR, i.e., into the isolated AS group and the ATTR-AS group.

transcatheter aortic valve replacement (TAVR)

Intervention Type: PROCEDURE

TAVR is a minimally invasive cardiac interventional procedure that delivers a compressed artificial aortic valve to the diseased aortic valve site via peripheral blood vessels (e.g., the femoral artery) or the apex of the heart through a catheter, releases and deploys the valve to replace the original diseased valve leaflets, thereby restoring normal valve function and treating severe aortic stenosis (AS).

AS group

Patients were grouped according to the presence or absence of ATTR, i.e., into the isolated AS group and the ATTR-AS group.

transcatheter aortic valve replacement (TAVR)

Intervention Type: PROCEDURE

TAVR is a minimally invasive cardiac interventional procedure that delivers a compressed artificial aortic valve to the diseased aortic valve site via peripheral blood vessels (e.g., the femoral artery) or the apex of the heart through a catheter, releases and deploys the valve to replace the original diseased valve leaflets, thereby restoring normal valve function and treating severe aortic stenosis (AS).

Interventions

transcatheter aortic valve replacement (TAVR)

TAVR is a minimally invasive cardiac interventional procedure that delivers a compressed artificial aortic valve to the diseased aortic valve site via peripheral blood vessels (e.g., the femoral artery) or the apex of the heart through a catheter, releases and deploys the valve to replace the original diseased valve leaflets, thereby restoring normal valve function and treating severe aortic stenosis (AS).

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daxin Zhou

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

Ming Li

Role: CONTACT

li.mingfei@zs-hospital.sh.cn

13564254007

Dan Tian

Role: CONTACT

tian.dan@zs-hospital.sh.cn

13916157135

Other Identifiers

CA-TAVR

Identifier Type: -

Identifier Source: org_study_id