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临床试验/NCT03631303
NCT03631303Unknown不适用

Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Evoked PESP-BP

研究概览

简要总结

Background: Patients at increased risk for sudden cardiac death (SCD) may receive an implantable cardioverter defibrillator (ICD). The primary criterion for a primary prevention ICD implantation is a left ventricular ejection fraction (LVEF) below 35%, but refinement of ICD criteria is important since only a small proportion of ICD patients receives appropriate device therapy (ATP or a shock) during follow-up. Post-extrasystolic potentiation (PESP) may be a new risk marker for SCD. PESP is defined as a temporary increase in contractility that follows an extrasystolic beat (ESB) and is associated with myocardial calcium handling. In heart failure, changes in calcium homeostasis may lead to afterdepolarisations and thus predispose for SCD. PESP can be measured indirectly and non-invasively as post-extrasystolic blood pressure potentiation (PESP-BP). Abnormal PESP-BP was previously found to be an independent predictor of increased mortality in post-myocardial infarction patients with a reduced LVEF. However, it is unknown if this increased mortality in heart failure patients with abnormal PESP-BP is caused by an increased risk of SCD.

Hypothesis: The investigators hypothesize that PESP-BP might be a new predictor of the occurrence of SCD, and can be used to enhance patient selection for primary prevention ICD therapy.

Design: During scheduled device replacement ESB with various extrasystolic and post-extrasystolic coupling intervals will be evoked by electrical stimulation via the right atrial and ventricular device leads of the patient. Throughout the stimulation study blood pressure will be measured non-invasively a continuous electrocardiogram will be recorded. Either before or after the procedure, patients will undergo a 30-minutes assessment of spontaneous ESB, again with blood pressure and ECG recordings.

Study population: 30 patients who are scheduled for device replacement or reposition, are eligible for this study; (1) 10 ICD patients who previously received appropriate device therapy (ADT); (2) 10 ICD patients who are free from ADT and (3) 10 dual-chamber pacemaker patients (control group).

Outcomes: (1) Evoked PESP-BP (i.e. blood pressure differences between baseline, ESB and post-ESB); (2) Spontaneous PESP-BP (i.e. blood pressure differences between baseline, ESB and post-ESB); (3) Timing parameters (in ms): the basic cycle length interval; Extra-systolic interval (ESI); Post-extrasystolic interval (PESI).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Implanted with a dual-chamber device
  • For ICD patients: a LVEF ≤35%, measured recently
  • For Pacemaker patients: a LVEF > 50% measured both recently
  • A device follow-up of at least one year must be available
  • Optimal (stable) medical therapy
  • Sinus rhythm

排除标准

  • Age <18 or incapacitated adult
  • Unknown left ventricular function prior to device implantation
  • Patients unwilling to participate
  • Documented atrial fibrillation
  • Second or third degree atrioventricular (AV) conduction disorders;
  • Patients with a cardiac resynchronization therapy (CRT-D) or one-chamber device
  • Hypertrophic cardiomyopathy
  • Conditions with insufficient blood flow to the fingers, e.g. M. Raynaud or conditions with extreme vasoconstriction

结局指标

主要结局

Evoked PESP-BP

时间窗: Measured during stimulation protocol

blood pressure differences between baseline, extrasystolic beat (ESB) and post-ESB

Spontaneous PESP-BP

时间窗: Measured in rest, without cardiac stimulation with spontaneous ESB

blood pressure differences between baseline, extrasystolic beat (ESB) and post-ESB

次要结局

未报告次要终点

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cornelis P. Allaart

Principal Investigator

Amsterdam UMC, location VUmc

研究点 (1)

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