Aortic StenosisNCT07170306
Cardiac Amyloidosis in Patients With Aortic Stenosis
An observational study of Aortic Stenosis and Transthyretin Amyloid Cardiomyopathy, run by Shanghai Zhongshan Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Aortic Stenosis, Transthyretin Amyloid Cardiomyopathy
- What is being tested?
- transcatheter aortic valve replacement (TAVR)
- Type of treatment
- Surgery or procedure
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2026to 31 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study on the Prevalence and Clinical Characteristics of 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.
Read the 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.
- Being tested
- transcatheter aortic valve replacement (TAVR)
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter aortic valve replacement (TAVR)Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: transcatheter aortic valve replacement (TAVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
NT-proBNP levels were measured at baseline, 1 month, 3 months, 6 months, and 12 months, and the change from baseline was evaluated.
Measured: baseline, 1 month, 3 months, 6 months, and 12 months
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
Measured: baseline, 1 month, 3 months, 6 months, and 12 months
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.
Measured: baseline, 6 months, and 12 months
Change in Left Ventricular Ejection Fraction (LVEF) from baseline
LVEF changes were evaluated at baseline, 1 month, 3 months, 6 months, and 12 months.
Measured: baseline, 1 month, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start31 Jan 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daxin Zhou, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170306
- Sponsor's protocol ID
- CA-TAVR
- Status last verified
- Jan 2026
- First submitted
- 5 Sep 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Prevalence and Clinical Characteristics of Cardiac Amyloidosis in Patients With Aortic Stenosis
- ClinicalTrials.gov ID
- NCT07170306
- Acronym / sponsor ID
- CA-TAVR
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATTR-AS group | – | Procedure: transcatheter aortic valve replacement (TAVR)Patients were grouped according to the presence or absence of ATTR, i.e., into the isolated AS group and the ATTR-AS group. |
| AS group | – | Procedure: transcatheter aortic valve replacement (TAVR)Patients were grouped according to the presence or absence of ATTR, i.e., into the isolated AS group and the ATTR-AS group. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | AS group, ATTR-AS group |
Primary outcome
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.
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.
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daxin Zhou principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Transthyretin Amyloid Cardiomyopathy, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Li (13564254007, li.mingfei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.