Ertugliflozin to Reduce Arrhythmic Burden in Implantable Cardioverter-defibrillators (ICD)/Cardiac Resynchronisation Therapy(CRT) patientS (ERASe-Trial) - a Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 55
- 试验地点
- 8
- 主要终点
- Change in Number of Supraventricular Tachycardia (svT)/ Ventricular Fibrillation (VF) Episodes
研究概览
简要总结
The recent study is planned to investigate the impact of Ertugliflozin on total burden of ventricular arrhythmias. Further objectives will be number of therapeutic interventions of implanted devices, atrial fibrillation, heart failure biomarker and changes in physical function quality of life, stress and anxiety.
详细描述
This is a randomized, double-blind (patients and physicians), placebo controlled multi-center study to evaluate the effect of ertugliflozin 5mg once daily (p.o.) for 52 weeks on the ventricular arrhythmic burden and markers of physical and mental well-being as well as biomarker for Heart Failure with reduced Ejection Fraction (HFrEF) and heart failure with mid-range ejection fraction (HFmrEF) patients with ICD±CRT therapy. The study will be conducted in 8 experienced sites in Austria with an aim to enrol 402 patients to evaluate the overall study hypothesis.
Therefore, three study visits will be carried out (baseline, 1-year follow-up visit and a telephone visit 4 weeks after visit 2). As part of the two on-site study visits, study-specific measures, a blood sample and an echocardiographic examination will be performed. The trial is completed by a telephone visit 4 weeks after the second on-site visit (week 52).
It is anticipated that the study will run for 30 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HFrEF or HFmrEF, and ICD±CRT therapy > 3 months
- •at least 10 documented VT episodes (either nsVT (non-sustained ventricular tachycardia) or sVT (sustained ventricular tachycardia) ± ICD (mplantable cardioverter-defibrillator) treatment) within the last 12 months plus:
- •nt-proBNP > 500pg/mL or
- •Left-ventricular Ejection Fraction (LV-EF) < 35% or
- •hospitalization for heart failure within the last 12 months or
- •> 100 nsVTs within the last 12 months
- •> 1 sVT/VF (ventricular function) within the last 12 months
- •Informed consent has to be given in written form.
- •estimated glomerular filtration rate (eGFR) > 30 ml/min/1.73m2
- •Blood pressure before first drug dosing: blood pressure systolic > 100 mmHg
- •Blood pressure before first drug dosing: blood pressure diastolic > 60 mmHg
排除标准
- •Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis
- •Ongoing ventricular arrhythmia
- •Known allergy to SGLT-2 inhibitors
- •Haemodynamic instability as defined by intravenous administration of catecholamine, calciumsensitizers or phosphodiesterase inhibitors
- •>1 episode of severe hypoglycemia within the last 6 months under treatment with insulin or sulfonylurea
- •Planned catheter ablation for ventricular arrhythmia
- •Planned explantation of ICD, or planned up/downgrade to/from CRT-D device
- •Existing therapy with SGLT-2 inhibitors
研究组 & 干预措施
Ertugliflozin
The subject will receive Ertugliflozin 5mg.
干预措施: Ertugliflozin 5 mg (Drug)
Placebo
The subject will receive Placebo 5mg.
干预措施: Placebo 5mg (Drug)
结局指标
主要结局
Change in Number of Supraventricular Tachycardia (svT)/ Ventricular Fibrillation (VF) Episodes
时间窗: 52 weeks
Change in number of supraventricular tachycardia (svT)/ ventricular fibrillation (VF) episodes from baseline to week 52
次要结局
- Number of Hospitalizations Due to Heart Failure(56 weeks)
- Duration of Hospital Stay(56 weeks)
- Cardiovascular Mortality(56 weeks)
- Number of Nonsustained Ventricular Tachycardia (nsVT) Episodes(52 weeks)
- Number of Episodes of Appropriate Implantable Cardioverter-defibrillator Therapies(52 weeks)
- Change in NTproBNP Levels(52 weeks)
- Change in HbA1c Levels(52 weeks)
- Number of Hospitalizations(56 weeks)
- Atleast One Hospitalization Due to Heart Failure(56 weeks)