Cardiac Amyloidosis in Patients With Aortic Stenosis

NCT07170306 | Not Yet Recruiting

• 1 other identifier: CA-TAVR
• Study Type: observational
• Target: 143
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Transthyretin Amyloid Cardiomyopathy; Aortic Stenosis

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

  12 months

• 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.

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

Secondary Outcomes (4)

• Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level from baseline

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

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

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

• Change in quality of life from baseline

  baseline, 6 months, and 12 months

• Change in Left Ventricular Ejection Fraction (LVEF) from baseline

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

Other Outcomes (6)

• Ventricular remodeling indices

  at baseline and 12 months

• Echocardiographic indices

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

• Change in cardiac troponin T (cTnT) level from baseline

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

Study Arms (2)

ATTR-AS group

Patients were grouped according to the presence or absence of ATTR, i.e., into the isolated AS group and the ATTR-AS group.

Procedure: transcatheter aortic valve replacement (TAVR)

AS group

Patients were grouped according to the presence or absence of ATTR, i.e., into the isolated AS group and the ATTR-AS group.

Procedure: transcatheter aortic valve replacement (TAVR)

Interventions

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).

AS group; ATTR-AS group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

On the morning of the day after admission, 4 mL of elbow venous blood was routinely collected. The supernatant was separated and aliquoted into 3 EP tubes (500 μL per tube), then stored in a -80°C refrigerator. Repeated freezing and thawing was avoided, and the samples were kept for subsequent analysis. Serum samples were thawed at room temperature for more than 30 minutes, and subsequent procedures were performed after complete thawing.

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Daxin Zhou

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Li

CONTACT

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

Dan Tian

CONTACT

13916157135; tian.dan@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: January 31, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share