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Screening of Pulmonary Hypertension in Methamphetamine Abusers (SOPHMA)

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ClinicalTrials.gov Identifier: NCT04019600
Recruitment Status : Not yet recruiting
First Posted : July 15, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. David Siu, The University of Hong Kong

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
Methamphetamine Abuse Pulmonary Hypertension 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Screening of Pulmonary Hypertension in Methamphetamine Abusers (SOPHMA): Rationale and Design of a Multicenter, Cross-sectional Study
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: 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.
    Other Names:
    • 12-lead electrocardiogram
    • Serum sampling for brain natriuretic peptide and other biomarkers
    • 6-minute walking test


Primary Outcome Measures :
  1. Diagnosis of PAH in methamphetamine users [ Time Frame: 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 [ Time Frame: 3 years ]
    Risk factors and a prediction model for PAH in methamphetamine users



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019600


Contacts
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Contact: Chung-Wah David Siu, MD 2255 3597 cwdsiu@hku.hk
Contact: Siu-Han JoJo Hai, MBBS 2255 4365 haishjj@hku.hk

Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Siu-Han JoJo Hai, MBBS The University of Hong Kong

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Responsible Party: Dr. David Siu, Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04019600     History of Changes
Other Study ID Numbers: SOPHMA study protocol_v.1
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors