Aortic Stenosis, Transthyretin Amyloid Cardiomyopathy
Conditions
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.
Interventions
PROCEDUREtranscatheter 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).
Sponsors
Shanghai Zhongshan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality Composite endpoint of death and first hospitalization for heart failure In accordance with | baseline, 1 month, 3 months, 6 months, and 12 months | All-cause mortality is a statistical measure that counts all deaths in a specific population over a given time period, regardless of the cause of death. |
| Composite endpoint of death and first hospitalization for heart failure | 12 months | In accordance with the Valve Academic Research Consortium-2 (VARC-2) criteria, the composite endpoints for early safety and clinical efficacy after transcatheter aortic valve replacement (TAVR) were evaluated. |
| Change in serum transthyretin (TTR) level from baseline | baseline, 1 month, 3 months, 6 months, and 12 months | At baseline, 1 month, 3 months, 6 months, 12 months, the serum TTR levels were measured to assess the changes compared to the baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level from baseline | baseline, 1 month, 3 months, 6 months, and 12 months | NT-proBNP levels were measured at baseline, 1 month, 3 months, 6 months, and 12 months, and the change from baseline was evaluated. |
| Change in New York Heart Association (NYHA) functional classification from baseline | baseline, 1 month, 3 months, 6 months, and 12 months | NYHA functional classification was assessed at baseline, 1 month, 3 months, 6 months, and 12 months, and the change from baseline was evaluated. The assessment was based on the New York Heart Association Functional Classification Scale, which is a 4-level ordinal scale with a minimum value of Class Ⅰ and a maximum value of Class Ⅳ. For this scale, higher scores represent worse clinical outcomes: Class Ⅰ: No limitation of physical activity Class Ⅱ: Slight limitation of physical activity Class Ⅲ: Marked limitation of physical activity Class Ⅳ: Unable to carry on any physical activity without symptoms |
| Change in quality of life from baseline | baseline, 6 months, and 12 months | In this study, the Minnesota Living With Heart Failure Questionnaire (MLHFQ) was used to assess patients' quality of life at baseline, 6 months, and 12 months. The MLHFQ corresponds to the full name Minnesota Living With Heart Failure Questionnaire, a disease-specific tool for evaluating heart failure-related quality of life. This scale has a total score range of 0 (minimum) to 105 (maximum). A higher total score reflects more severe quality of life impairment (i.e., worse outcome), while a lower score indicates better physical and psychological well-being in patients with heart failure. |
| Change in Left Ventricular Ejection Fraction (LVEF) from baseline | baseline, 1 month, 3 months, 6 months, and 12 months | LVEF changes were evaluated at baseline, 1 month, 3 months, 6 months, and 12 months. |
Contacts
CONTACTMing Li
CONTACTDan Tian
PRINCIPAL_INVESTIGATORDaxin Zhou
Fudan University
Outcome results
None listed