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临床试验/NCT05223725
NCT05223725撤回1 期

AdKCNH2-G628S Gene Therapy for Post-Operative Atrial Fibrillation

University of Massachusetts, Worcester1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2023年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
撤回
发起方
入组人数
78
试验地点
1
主要终点
proportion of patients having a post-operative complication relative to controls

研究概览

简要总结

This clinical trial will have 2 components: a brief dose-ranging study and a randomized comparison of 2 doses of AdKCNH2-G628S with control cardiac surgery patients. The study will assess safety of the intervention in a population at increased risk for post-operative atrial fibrillation.

详细描述

Post-operative AF (POAF) is a specific form of AF occurring in the days after cardiothoracic surgery. A unique element of POAF is the limited duration of risk, which peaks 3 days and dissipates 10 days after surgery. We propose gene therapy for POAF. Our hypothesis is that counteracting AF-related electrical remodeling will disrupt the reentrant electrical circuits integral to maintaining AF. We have extensive preclinical data showing safety and efficacy of adenoviral gene transfer using the gene mutation KNCH2-G628S. When delivered to the atria using adenoviruses and a novel gene painting technique, KCNH2-G628S effectively and specifically prolongs atrial action potential and prevents development of AF for the 10-14-day duration of post-operative AF risk. This clinical trial will have 2 components: a brief dose-ranging study and a randomized comparison of 2 doses of AdKCNH2-G628S with control cardiac surgery patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

participant is masked due to delivery during general anesthesia, outcomes assessors and investigators are fully masked to study group.

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

dose escalation

Experimental

initial phase, increasing dose

干预措施: AdKCNH2-G628S (Biological)

low dose

Experimental

second phase, fixed dose 5x10(11) vp

干预措施: AdKCNH2-G628S (Biological)

high dose

Experimental

second phase, fixed dose 2x10(12) vp

干预措施: AdKCNH2-G628S (Biological)

结局指标

主要结局

proportion of patients having a post-operative complication relative to controls

时间窗: 3 months

proportion of patients having a post-operative complication relative to controls

次要结局

  • proportion of patients having post-operative atrial fibrillation(1 month)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Sponsor

研究点 (1)

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