NCT03603158

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

Completed Last updated 30 July 2018

What this trial tests

trial in Opioid Dependence in 111 participants. Completed in 31 December 2012.

Timeline

1 February 2011

Primary endpoint
31 December 2012

31 December 2012

Quick facts

Lead sponsor	Universiti Sains Malaysia
Status	Completed
Study type	OBSERVATIONAL
Enrollment	111
Start date	1 February 2011
Primary completion	31 December 2012
Estimated completion	31 December 2012
Sites	1 location across Malaysia

Conditions studied

• Opioid Dependence — all drugs for Opioid Dependence →
• Methadone Toxicity — all drugs for Methadone Toxicity →
• HERG Gene Mutation — all drugs for HERG Gene Mutation →

Sponsor

Universiti Sains Malaysia — full company profile →

Who can join

18 and older, any sex, with Opioid Dependence or Methadone Toxicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A synonymous KCNH2 polymorphism and methadone trough level influence QTc prolongation in Kelantanese Malay recipients of methadone maintenance therapy (MMT) in Malaysia.
   Abdul Jalal MI, Abdullah-Zawawi MR, Musa N, Ghazali B, et al · · 2025 · cited 1× · PMID 40323987 · DOI 10.1371/journal.pone.0322724