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
|Condition or disease||Intervention/treatment|
|Methamphetamine Abuse Pulmonary Hypertension||Other: Echocardiography|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|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|
- 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
- Diagnosis of PAH in methamphetamine users [ Time Frame: 3 years ]Diagnosis and subtypes, as well as prevalence of PAH in methamphetamine users
- Risk factors of PAH in methamphetamine users [ Time Frame: 3 years ]Risk factors and a prediction model for PAH in methamphetamine users
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
|Contact: Chung-Wah David Siu, MD||2255 firstname.lastname@example.org|
|Contact: Siu-Han JoJo Hai, MBBS||2255 email@example.com|
|Principal Investigator:||Siu-Han JoJo Hai, MBBS||The University of Hong Kong|