Screening of Pulmonary Hypertension in Methamphetamine Abusers

NCT ID: NCT04019600

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-23
• Study Completion Date: 2022-12-22

Brief Summary

Methamphetamine is misuse if classified as a "likely" risk factor for pulmonary arterial hypertension (PAH). Nevertheless the actual prevalence of and a screening strategy for PAH in methamphetamine users have not been established. In this study, the prevalence of PAH will be investigated and its independent risk factors among methamphetamine users will be identified.

Detailed Description

Methamphetamine is a potent central nervous system stimulant originally prescribed for individuals with neuropsychiatric diseases. Owing to its highly addictive nature, illicit use has emerged as a major public health problem worldwide. It causes methamphetamine use disorders and also affects cardiovascular (CV) system.

PAH is one of those CV complications and is devastating and often life-threatening. In a subsequent retrospective cohort, patients with idiopathic PAH were found to have a much higher prevalence of prior use of methamphetamine and/or its related compounds, compared with patients with chronic thromboembolic pulmonary hypertension or pulmonary hypertension due to a known associated condition. Although current international guidelines recognize methamphetamines as a "likely" cause of drug-induced PAH, almost nothing is known about its prevalence and incidence amongst methamphetamine users.

Besides, since patients with PAH often remain asymptomatic in the early phase, the diagnosis is often made late in the course of the disease, when most small pulmonary arteries have been obliterated, rendering therapy ineffective. Although the prognosis of patients with methamphetamine-associated PAH appears to be much worse than for those with idiopathic PAH, international guidelines and expert consensus have not considered screening for PAH in asymptomatic methamphetamine users.

This study will apply a current guideline-recommended PAH screening algorithm for systemic sclerosis to a large cohort of unselected methamphetamine users in Hong Kong. The study objectives include: 1) to describe the prevalence of PAH among methamphetamine users using a current guidelines-recommended screening algorithm for PAH in systemic sclerosis; 2) to identify independent risk factors for PAH in methamphetamine users; and 3) to develop a prediction model for PAH in methamphetamine users.

Conditions

Methamphetamine Abuse; Pulmonary Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Echocardiography

Demographic data and health risk factors will be collected on day of screening, together with the above tests. Right heart catheterization will be separately arranged in patients with a high echocardiographic probability of PAH. For those with a low-intermediate echocardiographic probability, screening will be repeated within 1 year to ensure true negativity of the original scan.

Intervention Type: OTHER

Other Intervention Names

12-lead electrocardiogram; Serum sampling for brain natriuretic peptide and other biomarkers; 6-minute walking test

Eligibility Criteria

Inclusion Criteria

• >= 18 years at enrollment
• report of methamphetamine use in the last 2 years
• diagnosed as amphetamine dependent according to the Diagnostic and Statistical Manual of Mental Disorders (the 5th edition) (DSM-V)(13)
• voluntarily agree to participate by providing written informed consent

Exclusion Criteria

• failed or refused to provide written informed consent

Reference:

13. Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas 2013;25(2):191-2.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Chung-Wah David SIU

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siu-Han JoJo Hai, MBBS

Role: PRINCIPAL_INVESTIGATOR

Cardiac Division, the University of Hong Kong

Locations

Queen Mary Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

SOPHMA study protocol_v.1

Identifier Type: -

Identifier Source: org_study_id