Not Yet RecruitingNot Applicable

Cardiac Amyloidosis in Patients With Aortic Stenosis

143 participantsStarted 2026-01-31

Plain-language 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.

Who can participate

Age range65 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

All-cause mortality Composite endpoint of death and first hospitalization for heart failure In accordance with

Timeframe: baseline, 1 month, 3 months, 6 months, and 12 months

Composite endpoint of death and first hospitalization for heart failure

Timeframe: 12 months

Change in serum transthyretin (TTR) level from baseline

Timeframe: baseline, 1 month, 3 months, 6 months, and 12 months

Trial details

NCT IDNCT07170306

SponsorShanghai Zhongshan Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-05-31

Contact for this trial

Ming Li

13564254007 li.mingfei@zs-hospital.sh.cn

View on ClinicalTrials.gov More Aortic Stenosis trials

Plain-language summary

Who can participate

Age range65 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

All-cause mortality Composite endpoint of death and first hospitalization for heart failure In accordance with

Timeframe: baseline, 1 month, 3 months, 6 months, and 12 months

Composite endpoint of death and first hospitalization for heart failure

Timeframe: 12 months

Change in serum transthyretin (TTR) level from baseline

Timeframe: baseline, 1 month, 3 months, 6 months, and 12 months