A Study on the Prevalence and Clinical Characteristics of Cardiac Amyloidosis in Patients With Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 143
- 主要终点
- All-cause mortality Composite endpoint of death and first hospitalization for heart failure In accordance with
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
All-cause mortality Composite endpoint of death and first hospitalization for heart failure In accordance with
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in Left Ventricular Ejection Fraction (LVEF) from baseline(baseline, 1 month, 3 months, 6 months, and 12 months)
- Change in 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)