SOPHMA: Screening of Pulmonary Hypertension in Methamphetamine Abusers

Sponsor
The University of Hong Kong (Other)
Overall Status
Suspended
CT.gov ID
NCT04019600
Collaborator
(none)
200
1
36
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Echocardiography

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Screening of Pulmonary Hypertension in Methamphetamine Abusers (SOPHMA): Rationale and Design of a Multicenter, Cross-sectional Study
Actual Study Start Date :
Dec 23, 2019
Anticipated Primary Completion Date :
Dec 22, 2022
Anticipated Study Completion Date :
Dec 22, 2022

Outcome Measures

Primary Outcome Measures

  1. Diagnosis of PAH in methamphetamine users [3 years]

    Diagnosis and subtypes, as well as prevalence of PAH in methamphetamine users

Secondary Outcome Measures

  1. Risk factors of PAH in methamphetamine users [3 years]

    Risk factors and a prediction model for PAH in methamphetamine users

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  1. Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas 2013;25(2):191-2.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Mary Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Siu-Han JoJo Hai, MBBS, Cardiac Division, the University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Chung-Wah David SIU, Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04019600
Other Study ID Numbers:
  • SOPHMA study protocol_v.1
First Posted:
Jul 15, 2019
Last Update Posted:
Aug 10, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2021