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临床试验/NCT03603158
NCT03603158已完成不适用

Influence of KCNH2 Polymorphisms on the QTc Interval in Kelantanese Malays Patients Receiving Methadone Maintenance Therapy (MMT) in Malaysia

Universiti Sains Malaysia1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2011年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
111
试验地点
1
主要终点
QTc Interval

研究概览

简要总结

Methadone maintenance therapy (MMT) is one of the modalities to prevent HIV transmission among injected drug users, particularly in opioid-dependent users. However, methadone-associated cardiotoxicity is one of the fatal adverse events that limit the widespread usage in certain groups of opioid-dependent patients. This is a cross-sectional study aimed to investigate the association between 4 KCNH2 SNPs (1539C>T, in exon 6 of KCNH2 gene; 1956T>C, in exon 8 of KCNH2 gene), 2350C>T (in exon 9 of KCNH2 gene), 2690A>C (Exon 11 of KCNH2 gene)) and prolongation of QTc interval in opioid-dependent Kelantanese Malays who are the recipients of Methadone Maintenance Therapy. The investigators hypothesized that subjects with minor alleles of those 4 SNPs will have longer QTc intervals than those with major alleles, adjusting for the effects of other confounding factors such as age and gender of the subjects, plasma methadone trough levels, hypokalemia, hypocalcemia and hypomagnesemia. The investigators also aimed to provide a model that will reliably predict the magnitude QTc based on the SNPs data and other covariates mentioned above. This will greatly assist in identifying methadone recipients who are at risk of developing prolonged QTc or the more fatal torsade de pointes.

详细描述

Introduction

Methadone maintenance therapy (MMT) is one of the modalities to prevent HIV transmission among injected drug users, particularly in opioid-dependent users. However, methadone-associated cardiotoxicity is one of the fatal adverse events that limit the widespread usage in certain groups of opioid-dependent patients.

Study hypotheses / aims

The investigators hypothesized that subjects with minor alleles of those 4 SNPs would have longer QTc intervals than those with major alleles, adjusting for the effects of other confounding factors such as age and gender of the subjects, plasma methadone trough levels, hypokalemia, hypocalcemia and hypomagnesemia. The investigators also aimed to provide a model that will reliably predict the magnitude QTc based on the SNPs data and other covariates mentioned above. This will greatly assist in identifying methadone recipients who are at risk of developing prolonged QTc or the more fatal torsade de pointes.

Study Design and Sample Size Calculation

研究设计

研究类型
Observational
观察模型
Other
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

  • Opioid-dependent subjects aged 18 years and above
  • Opioid-dependent subjects who were on Methadone Maintenance Therapy (MMT) for 6 months or longer and had stable plasma methadone concentration
  • Malay ancestry up to 3 generations
  • A history of good compliance with Directly-Observed Therapy (DOT)

排除标准

  • Opioid-dependent subjects who were aggressive and had active psychiatric illnesses
  • Opioid-dependent subjects with chronic medical and surgical illnesses
  • Opioid-dependent subjects with cardiac structural defects
  • Inability to communicate in Malay or English

结局指标

主要结局

QTc Interval

时间窗: First screening visit

QT interval (measured in milliseconds) obtained from ECG reading that is then divided by the shortest R-R interval to the power of 0.33 (Fredericia's formula).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Irfan Abdul Jalal

Principal Investigator

Universiti Sains Malaysia

研究点 (1)

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