SGLT2 Inhibitors in Adult Patients With Heart Failure Related to Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate, on real-life data, the efficacy of iSGLT2 in patients with heart failure related to congenital heart disease as defined by improvement in NYHA class and/or change in NT-proBNP.
研究概览
简要总结
Heart failure (HF) in adult patients with congenital heart disease is a major cause of morbidity and mortality. Approximately 30% of patients with significant congenital heart disease will develop signs of heart failure. Heart failure leads to hospitalization and disability with a longer hospital stay and higher health care costs as compared to heart failure patients without congenital heart disease. One-third of deaths in patients with congenital heart disease are attributable to heart failure.
In patients with heart failure and reduced ejection fraction (EF), 2021 ESC recommendations suggest the use of sodium-glucose co-transporter 2 inhibitors (SGLT2i) (dapaglifozin and empaglifozin), a new therapeutic class for heart failure (HF), in a class IA recommendation. In addition to reduced EF, these molecules have shown efficacy in preserved EF, leading to their reimbursement in both preserved and reduced ejection fraction in France.
Unfortunately, given the relatively low number of HF-congenital heart disease, patients, they were not included in previous studies. However, the seriousness of their condition and the absence of therapeutic explain the prescription of SGLT2i in those patients and the likelihood of increased use in the future. This especially underlines the need for safety data in this real-world population.
To date, no data on the safety or efficacy of SGLT2i in HF-congenital heart disease have been published. The results of this study would provide reassurance about the safety of SGLT2i in adult congenital patients and potentially expand the indication of SGLT2i in HF related to congenital heart disease
The objective of this study is to assess on real-life data, through a multicenter registry:
- The efficacy of SGLT2i in patients with heart failure related to congenital heart disease - The indications of SGLT2i use (type of congenital heart disease)
- The safety of SGLT2i (collection of adverse events)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients ≥ 18 years of age
- •Congenital heart disease (repaired, unrepaired, or palliated) with clinical heart failure NYHA class II, III, or IV at the time of SGLT2i initiation B59
- •Patient in whom SGLT2i therapy has been started within the previous 12 months or is started at the time of the visit.
- •Registered to the French social security system
排除标准
- •Opposition of the patient to the use of his/her data
结局指标
主要结局
To evaluate, on real-life data, the efficacy of iSGLT2 in patients with heart failure related to congenital heart disease as defined by improvement in NYHA class and/or change in NT-proBNP.
时间窗: 6 to 12 months after SGLT2i introduction
Efficacy of SGLT2i therapy will be assessed by a composite endpoint including NT-proBNP and NYHA class. Thus, a patient with any improvement (decrease) in the biomarker (NT-proBNP) and/or improvement in at least 1 NYHA class will be defined as successful with SGLT2i therapy. The success rate in the target population will be calculated at the end of the study follow-up
次要结局
- To compare the evolution of biological stress test parameters of SGLT2i in patients with heart failure related to congenital heart disease treated with iSGLT2.(6-12 months after SGLT2i introduction)
- To describe the population of adults with congenital heart disease on SGLT2i prescription(6-12 months after SGLT2i introduction)
- Incidence of Treatment-Emergent Adverse Event in patients with heart failure related to congenital heart disease.[Safety and Tolerability](6-12 months after SGLT2i introduction)
- To evaluate the overall survival of heart failure related to congenital heart disease patients on SGLT2i after 12 months(6-12 months after SGLT2i introduction)