Safety and Efficacy of Dapagliflozin in Adult Patients With a Systemic Right Ventricle
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Nt-proBNP
研究概览
简要总结
The purpose of this study is to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.
详细描述
This is a prospective double arm study aiming to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.
Dapagliflozin will be prescribed in a group of randomly selected patients in addition to the optimized medical therapy for heart failure with reduced ejection fraction.
Changes in quality of life indicators, symptoms, biohumoral markers, exercise capacity and echocardiographic parameters of systolic right ventricular function will be evaluated in comparison with the control group, which will continue standard heart failure therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18years
- •Optimal medical therapy or at least 3months
- •Systemic right ventricle ejection fraction≤40%, assessed on echocardiography
排除标准
- •Univentricular physiology
- •Systolic blood pressure<90mmHg
- •Glomerular filtration rate(GFR)<30ml/min
研究组 & 干预措施
Dapagliflozin
Dapagliflozin will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction
干预措施: Dapagliflozin 10mg Tab (Drug)
结局指标
主要结局
Nt-proBNP
时间窗: 1 year
Systemic right ventricle fractional area change
时间窗: 1 year
Adverse Events
时间窗: 1 year
Absence of any suspected or confirmed adverse events or necessity of drug discontinuation
Systemic right ventricle global longitudinal strain
时间窗: 1 year
次要结局
未报告次要终点
研究者
Flavia Fusco
Medical Doctor
Monaldi Hospital