Cardiac Amyloidosis in Patients With Aortic Stenosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65-85
SponsorShanghai Zhongshan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
Patients admitted to the Cardiology Ward who undergo transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) from May 2025 to May 2028.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
transcatheter aortic valve replacement (TAVR)
Procedure/SurgeryTAVR 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).
Treatment groups
143 Participants
are divided into 2 treatment groupsGroup A: ATTR-AS group1 intervention
Group B: AS group1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality Composite endpoint of death and first hospitalization for heart failure In accordance with
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.
Time frame
baseline, 1 month, 3 months, 6 months, and 12 months2
Composite endpoint of death and first hospitalization for heart failure
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.
Time frame
12 months3
Change in serum transthyretin (TTR) level from baseline
At baseline, 1 month, 3 months, 6 months, 12 months, the serum TTR levels were measured to assess the changes compared to the baseline.
Time frame
baseline, 1 month, 3 months, 6 months, and 12 monthsSecondary outcomes
1
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level from baseline
NT-proBNP levels were measured at baseline, 1 month, 3 months, 6 months, and 12 months, and the change from baseline was evaluated.
Time frame
baseline, 1 month, 3 months, 6 months, and 12 months2
Change in New York Heart Association (NYHA) functional classification from baseline
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
Time frame
baseline, 1 month, 3 months, 6 months, and 12 months3
Change in quality of life from baseline
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.
Time frame
baseline, 6 months, and 12 months4
Change in Left Ventricular Ejection Fraction (LVEF) from baseline
LVEF changes were evaluated at baseline, 1 month, 3 months, 6 months, and 12 months.
Time frame
baseline, 1 month, 3 months, 6 months, and 12 monthsOther outcomes
1
Ventricular remodeling indices
Cardiac Magnetic Resonance (CMR) was used to assess patients' ventricular function and structure at baseline and 12 months.
Time frame
at baseline and 12 months2
Echocardiographic indices
Echocardiography was used to assess ventricular systolic function at baseline, 1 month, 3 months, 6 months, and 12 months.
Time frame
baseline, 1 month, 3 months, 6 months, and 12 months3
Change in cardiac troponin T (cTnT) level from baseline
The change in cTnT level from baseline was evaluated at baseline, 1 month, 3 months, 6 months, and 12 months.
Time frame
baseline, 1 month, 3 months, 6 months, and 12 months4
99Tcm-phosphonate (99Tcm-PYP) bone scan indices
Patients underwent 99Tcm-PYP bone scans at baseline and 12 months, and the visual scoring grades and heart/contralateral lung (H/CL) ratios were recorded.
Time frame
baseline, 12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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