A Multicenter, Interventional, Open-label and Single-arm Study to Investigate the Effect of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Proportion of Paired Patients With Ventricular Arrhythmia (VA) Events
研究概览
简要总结
The purpose of this study was to generate effectiveness data of Angiotensin receptor neprilysin inhibitor (ARNI), in the Chinese Heart failure with reduced ejection fraction (HFrEF) patients with implantable cardioverted defibrillator (ICD) or Cardiac resynchronization therapy-defibrillator (CRT-D).
详细描述
The rationale of this study was to compare the effect of angiotensin-converting enzyme inhibitor (ACEI) / Angiotensin receptor blockers (ARB) with the effect of ARNI on ventricular arrhythmia (VA) events for HFrEF patients with ICD or CRT-D, thus a multicenter, interventional, open-label, and prospective single-arm study was considered.
ACEI/ARB was given to the patient for 6 months. After 6 months, patients using ACEI needed to undergo a 36-hr washout period (36-hr washout period was not needed for patients using ARB at month 6). Patients then received ARNI (sponsored by Novartis only for this study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ACEI/ARB treatment for 6 months/ARNI treatment the next 6 months
Patients received angiotensin-converting enzyme inhibitor/angiotensin receptor blockers treatment the first 6 months. The following 6 months patients received angiotensin receptor neprilysin inhibitor treatment.
干预措施: ACEI/ARB (Drug)
ACEI/ARB treatment for 6 months/ARNI treatment the next 6 months
Patients received angiotensin-converting enzyme inhibitor/angiotensin receptor blockers treatment the first 6 months. The following 6 months patients received angiotensin receptor neprilysin inhibitor treatment.
干预措施: ARNI (Drug)
结局指标
主要结局
Proportion of Paired Patients With Ventricular Arrhythmia (VA) Events
时间窗: Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment)
VA events were measured through devices to determine sustained ventricular tachycardia (SVT), non-sustained ventricular tachycardia (NSVT) and premature ventricular contraction (PVC). SVT was defined as tachycardia lasting for ≥30 seconds or with hemodynamic disorder as determined by Holter and/or device. NSVT was defined as recorded by Holter and/or device. PVC was defined as an early ventricular depolarization as determined by the device, and/or detected by Holter. PVC data were not available for patients with single -lumen implantation type
Proportion of Paired Patients Who Experienced at Least One ICD or CRT-D Shock and ATP Event
时间窗: Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment)
Once VA events were detected, implantable cardioverter defibrillator (ICD) could treat with high-energy shocks or Anti-tachycardia pacing (ATP). ATP consists of one or more trains of pacing stimuli, expressed as a percentage of the tachycardia cycle length for a given RR interval, from the onset of the preceding R wave. Patients with sustained VA events would receive ICD or cardiac resynchronization therapy-defibrillator (CRT-D) shock therapy.
次要结局
- Pairwise Number of SVT, NSVT, PVC, ICD or CRT-D Shocks and ATP Events Experienced by Patients(Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment))
- Left Ventricular Ejection Fraction(Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment))
- New York Heart Association Classification(Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment))
- N-Terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Level(Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment))
- Number of Hospitalizations for Arrhythmia or HF Related Hospitalizations(Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment))