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Набор скоро начнётся NCT07170306

Cardiac Amyloidosis in Patients With Aortic Stenosis

— Наблюдательное Aortic Stenosis Transthyretin Amyloid Cardiomyopathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: transcatheter aortic valve replacement (TAVR).
Кому может быть актуально
Состояния в реестре: Aortic Stenosis, Transthyretin Amyloid Cardiomyopathy. Базовые параметры: 65 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура 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).

Первичные конечные точки

  • All-cause mortality Composite endpoint of death and first hospitalization for heart failure In accordance with [Срок оценки: baseline, 1 month, 3 months, 6 months, and 12 months]
  • Composite endpoint of death and first hospitalization for heart failure [Срок оценки: 12 months]
  • Change in serum transthyretin (TTR) level from baseline [Срок оценки: baseline, 1 month, 3 months, 6 months, and 12 months]
Вторичные конечные точки (4)
  • Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level from baseline [Срок оценки: baseline, 1 month, 3 months, 6 months, and 12 months]
  • Change in New York Heart Association (NYHA) functional classification from baseline [Срок оценки: baseline, 1 month, 3 months, 6 months, and 12 months]
  • Change in quality of life from baseline [Срок оценки: baseline, 6 months, and 12 months]
  • Change in Left Ventricular Ejection Fraction (LVEF) from baseline [Срок оценки: baseline, 1 month, 3 months, 6 months, and 12 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07170306 · CA-TAVR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗