Clinical trial NCT04019600: Screening of Pulmonary Hypertension in Methamphetamine Abusers
Official title: Screening of Pulmonary Hypertension in Methamphetamine Abusers (SOPHMA): Rationale and Design of a Multicenter, Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Methamphetamine Abuse
Pulmonary Hypertension
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a history of methamphetamine use followed-up in the participating substance abuse clinic will be identified via the computerized database of the clinical management system.

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.

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.

Primary outcomes:
measure: Diagnosis of PAH in methamphetamine users
timeFrame: 3 years
Secondary outcomes:
measure: Risk factors of PAH in methamphetamine users
timeFrame: 3 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: Cardiac Division, the University of Hong Kong
name: Siu-Han JoJo Hai, MBBS
role: PRINCIPAL_INVESTIGATOR
References: