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NCT Number: NCT07170306

Cardiac Amyloidosis in Patients With Aortic Stenosis

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Transthyretin Amyloid Cardiomyopathy Ventricular Outflow Obstruction

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transcatheter aortic valve replacement (TAVR)

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).

Primary outcomes

  1. 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

    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.

  2. Composite endpoint of death and first hospitalization for heart failure

    Time frame: 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.

  3. Change in serum transthyretin (TTR) level from baseline

    Time frame: 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 outcomes

  1. 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

    NT-proBNP levels were measured at baseline, 1 month, 3 months, 6 months, and 12 months, and the change from baseline was evaluated.

  2. Change in New York Heart Association (NYHA) functional classification from baseline

    Time frame: 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

  3. Change in quality of life from baseline

    Time frame: 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.

  4. Change in Left Ventricular Ejection Fraction (LVEF) from baseline

    Time frame: 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.

Other outcomes

  1. Ventricular remodeling indices

    Time frame: at baseline and 12 months

    Cardiac Magnetic Resonance (CMR) was used to assess patients' ventricular function and structure at baseline and 12 months.

  2. Echocardiographic indices

    Time frame: baseline, 1 month, 3 months, 6 months, and 12 months

    Echocardiography was used to assess ventricular systolic function at baseline, 1 month, 3 months, 6 months, and 12 months.

  3. Change in cardiac troponin T (cTnT) level from baseline

    Time frame: baseline, 1 month, 3 months, 6 months, and 12 months

    The change in cTnT level from baseline was evaluated at baseline, 1 month, 3 months, 6 months, and 12 months.

  4. 99Tcm-phosphonate (99Tcm-PYP) bone scan indices

    Time frame: baseline, 12 months

    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.

  5. Incidence of postprocedural complications

    Time frame: 1 month

    Incidence of postprocedural complications, such as acute kidney injury, major bleeding, vascular complications, stroke, and new pacemaker implantation.

  6. Number of participants with adverse events (AEs) and serious adverse events (SAEs) within 12 months

    Time frame: 12 months

    Number of participants with one or more AEs and SAEs within 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Tian

CONTACT

[email protected]

13916157135

Ming Li

CONTACT

[email protected]

13564254007

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

A Study on the Prevalence and Clinical Characteristics of Cardiac Amyloidosis in Patients With Aortic Stenosis

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 12, 2025
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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