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临床试验/NCT01163422
NCT01163422Unknown不适用

Long-term Right Ventricular Resynchronization Therapy for Chronic Thromboembolic Pulmonary Hypertension

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Improvement in right/left ventricular synchrony measured using tissue Doppler echocardiography

研究概览

简要总结

The purpose of this study is to determine whether cardiac resynchronization therapy with the use of an implanted electronic pacemaker reduces morbidity associated with chronic thromboembolic pulmonary hypertension

详细描述

Rationale: The clinical severity of right ventricular disease is largely determined by right-to-left ventricular dyssynchrony, i.e., delay of electrical activity between the right and left ventricles. Moreover, in patients with chronic thromboembolic pulmonary hypertension (CTEPH), we found that acute correction of this dyssynchrony by temporary pacing (prior to pulmonary endarterectomy, presently the therapy of choice for CTEPH) results in significant improvement in cardiac output. In this study, we aim to establish whether chronic pacing with the use of implanted pacemakers confers long-lasting improvements in cardiac output and functional class.

Objective: To study whether chronic pacing with implanted pacemakers confers long-lasting improvements in cardiac output and functional class in severely symptomatic CTEPH patients who are not eligible for pulmonary endarterectomy, or those in whom pulmonary endarterectomy has failed.

Study design: Chronic intervention study, double-blinded, randomized, cross-over.

Study population: Adult CTEPH patients who are not eligible for pulmonary endarterectomy, or those in whom pulmonary endarterectomy has failed.

Intervention (if applicable): chronic right ventricular resynchronization therapy (RVRT), i.e., chronic right atrial, right ventricular, and left ventricular pacing with the use of implanted pacemakers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • Adult patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are ineligible for pulmonary endarterectomy, and those in whom pulmonary endarterectomy has failed

排除标准

  • 未提供

研究组 & 干预措施

Immediate RVRT

Active Comparator

RVRT switched on immediately after pacemaker implant

干预措施: Implantation of 3-chamber pacemaker (Device)

Delayed RVRT

Placebo Comparator

RVRT switched on 4 weeks after pacemaker implant

干预措施: Implantation of 3-chamber pacemaker (Device)

结局指标

主要结局

Improvement in right/left ventricular synchrony measured using tissue Doppler echocardiography

时间窗: within 8 months after pacemaker implantation

Increase in cardiac output measured using Doppler echocardiography and scintigraphy

时间窗: within 8 months after pacemaker implantation

Increase in functional capacity measured with six-minute walking distance

时间窗: within 8 months after pacemaker implantation

次要结局

  • Increase in well-being assessed with questionnaire(within 8 months after pacemaker implantation)

研究者

研究点 (1)

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