ClinicalTrials.gov record NCT07170306

Cardiac Amyloidosis in Patients With Aortic Stenosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age65 years old to 85 years old
SexAll
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study follows people aged 65–85 with moderate-to-severe degenerative aortic stenosis who are scheduled for transcatheter aortic valve replacement (TAVR). It will estimate how common transthyretin cardiac amyloidosis is in this group, compare clinical characteristics between isolated AS and AS with ATTR, and track changes in blood transthyretin (TTR) and clinical outcomes up to 12 months after TAVR.

What it is studying. The study is testing how often transthyretin cardiac amyloidosis occurs in people having TAVR for moderate-to-severe degenerative aortic stenosis, how clinical features differ between those with isolated AS and those with ATTR-complicated AS, and whether TAVR is associated with changes in serum transthyretin (TTR) levels and in clinical outcomes over a one-year follow-up.

What the researchers hope to learn. To estimate the prevalence of transthyretin cardiac amyloidosis among people with aortic stenosis, to compare clinical characteristics of isolated AS versus ATTR-AS, and to describe changes in serum TTR and clinical outcomes after TAVR.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Procedure
  • transcatheter aortic valve replacement (TAVR)

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have the planned TAVR procedure as part of their care. The study will collect blood tests (including serum transthyretin/TTR and NT‑proBNP), assess heart function (left ventricular ejection fraction), and record NYHA functional class at baseline and at 1, 3, 6 and 12 months; quality of life (Minnesota Living With Heart Failure Questionnaire) is collected at baseline, 6 and 12 months. The study will track hospitalizations for heart failure and deaths over 12 months. Participants will be grouped for analysis by whether they have transthyretin amyloid cardiomyopathy (ATTR‑AS) or isolated AS.

How the study is structured. A prospective observational cohort. People scheduled for TAVR are grouped by whether they have transthyretin cardiac amyloidosis (ATTR) or not. Participants receive TAVR as their clinical care and are followed with blood tests, heart function assessments, symptom/classification checks, and quality-of-life questionnaires; the registry lists the quality-of-life questionnaire (MLHFQ) at baseline, 6 months and 12 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Aortic Stenosis; Transthyretin Amyloid Cardiomyopathy. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • No sites are listed on the registry yet. Where will the study take place?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 31, 2026 (estimated)
Primary completion
May 31, 2028 (estimated)
Study completion
May 31, 2028 (estimated)
Target enrollment
143 participants (estimated)
Last updated on registry
Jan 20, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Shanghai Zhongshan Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

Informed Consent Form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
investigational
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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