Effect of pharmacological treatment with angiotensin receptor/neprilysin inhibitors on transthyretin cardiac amyloidosis and heart failure with reduced ejection fraction (SAVA-TTR trial)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
- 入组人数
- 114
- 试验地点
- 4
- 主要终点
- Change in left ventricular ejection fraction (%), assessed by echocardiogram, compared to baseline value after 12-month treatment with Sacubitrl/Valsartan versus management without Sacubitril/Valsartan. An improvement in left ventricular ejection fraction will be defined as an increase of ≥ 5% between the baseline echocardiogram and the 12-month echocardiogram.
研究概览
简要总结
The primary objective is to determine the impact of treatment with Sacubitril/Valsartan on systolic function in patients with transthyretin amyloid cardiomyopathy and heart failure with reduced ejection fraction, by assessing the change in left ventricular ejection fraction in echocardiogram at 12 months.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age of both sexes.
- •Patients diagnosed with transthyretin amyloid cardiomyopathy, both in its hereditary form (ATTRv) or wild-type form (ATTRwt). The diagnosis of ATTR will be based on histological demonstration of TTR amyloid deposition or non-invasive criteria as indicated in guidelines. For ATTRv diagnosis, demonstration of causal TTR mutation through genetic testing will be required.
- •Patients initially evaluated or under follow-up in Cardiomyopathy/Heart Failure/Amyloidosis Units at participating centers.
- •Presenting with heart failure and reduced ejection fraction: LVEF ≤40%, in functional class I, II, or III according to the New York Heart Association (NYHA).
排除标准
- •NYHA Functional Class IV.
- •Stage 4 and 5 chronic kidney disease (creatinine clearance by CKD-EPI <30 mL/min/1.73m²).
- •Hyperkalemia (blood potassium levels > 5.4 mmol/L).
- •Hypotension defined as systolic blood pressure <100 mmHg on two consecutive measurements.
- •Treatment with ACE inhibitors (IECA), angiotensin II receptor blockers (ARAII), or sacubitril/valsartan at the time of enrollment.
- •History of angioedema or hypersensitivity to ACE inhibitors or angiotensin II receptor blockers.
- •Treatment with transthyretin gene silencers or diflunisal.
- •Participation in another clinical trial or any condition that, in the investigator's opinion, compromises participation in the study.
- •Pregnancy, breastfeeding, or fertile women unwilling to use adequate contraception throughout the study duration.
结局指标
主要结局
Change in left ventricular ejection fraction (%), assessed by echocardiogram, compared to baseline value after 12-month treatment with Sacubitrl/Valsartan versus management without Sacubitril/Valsartan. An improvement in left ventricular ejection fraction will be defined as an increase of ≥ 5% between the baseline echocardiogram and the 12-month echocardiogram.
Change in left ventricular ejection fraction (%), assessed by echocardiogram, compared to baseline value after 12-month treatment with Sacubitrl/Valsartan versus management without Sacubitril/Valsartan. An improvement in left ventricular ejection fraction will be defined as an increase of ≥ 5% between the baseline echocardiogram and the 12-month echocardiogram.
次要结局
未报告次要终点
研究者
Cristina Avendaño Solá
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda