Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i (ACHIEVE-SGLT2i) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 11
- 主要终点
- Prescription patterns
研究概览
简要总结
This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.
详细描述
In the adult congenital heart disease (ACHD) population, heart failure currently represents the main cause of morbidity and mortality. The etiology of ACHD-related heart failure is heterogenous, and there is limited evidence for pharmacological treatment options for this population.
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a novel pillar in the treatment of conventional LV heart failure. SGLT2i have been shown to reduce the risk of worsening heart failure and cardiovascular-related death in patients with LV heart failure.
While the exact mechanisms of action are still to be elucidated, SGLT2i seem to address heart failure by targeting several pathways. These include but are not limited to; a decrease in renin-angiotensin and sympathetic nervous system activation, a decrease in pressure overload-induced myocardial fibrosis, reverse cardiac remodeling, and improvement in myocardial energetics.
Given the compelling evidence on the effectiveness of SGLT2i over a broad range of cardiac dysfunction and initial promising reports of its utilization in the field of ACHD, SGLT2i deserve further exploration in the group of ACHD patients.
This real-world, international registry aims to evaluate the current experience with SGLT2i in ACHD patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.
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
- •Congenital heart defect.
- •Age ≥ 18 years.
- •Initiated on treatment with an SGLT2i.
排除标准
- •- No consent for data collection.
研究组 & 干预措施
ACHD patients treated with SGLT2i
All participants included in the registry have to have a congenital heart defect, be ≥ 18 years old, and receive (or have received) treatment with SGLT2i.
干预措施: SGLT2 inhibitors (Drug)
结局指标
主要结局
Prescription patterns
时间窗: Baseline information.
The primary outcome of this registry is an overview of the prescription patterns of SGLT2i in the ACHD population.
次要结局
- Clinical parameters - diastolic blood pressure [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Clinical parameters - heart rate [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Clinical parameters - saturation [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Laboratory parameters - sodium [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Laboratory parameters - potassium [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Laboratory parameters - creatinine [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Laboratory parameters - eGFR [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Laboratory parameters - NT-proBNP [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Laboratory parameters - glucose [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - LV FAC [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - RV function [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - RV GLS [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - RV FAC [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - RV S' [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - TAPSE [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Exercise parameters - 6MWT [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Exercise parameters - maximum performance [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Exercise parameters - validity [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Exercise parameters - VO2 max [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Exercise parameters - %-predicted VO2 max [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Concomitant medication changes [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Side effects [Safety and Tolerability](From enrollment through study completion, with an average follow-up duration of 1 year.)
- SGLT2i-related complications [Safety and Tolerability](From enrollment through study completion, with an average follow-up duration of 1 year.)
- SGLT2i discontinuation [Safety and Tolerability](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Mortality [Safety and Tolerability](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Admissions [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Clinical parameters - weight [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Clinical parameters - systolic blood pressure [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Laboratory parameters - HbA1c [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - LV function [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - LV GLS [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
研究者
Anastasia D. Egorova, MD, PhD
Principal Investigator
Leiden University Medical Center