Cardiac Amyloidosis in Patients With Aortic Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcatheter aortic valve replacement (TAVR).
- Who it may be relevant to
- Registry conditions: Aortic Stenosis, Transthyretin Amyloid Cardiomyopathy. Basic parameters: 65 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study on the Prevalence and Clinical Characteristics of Cardiac Amyloidosis in Patients With Aortic Stenosis
Overview
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.
Interventions
- Procedure 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).
Primary outcome measures
- All-cause mortality Composite endpoint of death and first hospitalization for heart failure In accordance with [Time frame: baseline, 1 month, 3 months, 6 months, and 12 months]
- Composite endpoint of death and first hospitalization for heart failure [Time frame: 12 months]
- Change in serum transthyretin (TTR) level from baseline [Time frame: baseline, 1 month, 3 months, 6 months, and 12 months]
Secondary outcome measures (4)
- Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level from baseline [Time frame: baseline, 1 month, 3 months, 6 months, and 12 months]
- Change in New York Heart Association (NYHA) functional classification from baseline [Time frame: baseline, 1 month, 3 months, 6 months, and 12 months]
- Change in quality of life from baseline [Time frame: baseline, 6 months, and 12 months]
- Change in Left Ventricular Ejection Fraction (LVEF) from baseline [Time frame: baseline, 1 month, 3 months, 6 months, and 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07170306 · CA-TAVR