Clinical observational retrospective cohort study in patients with pulmonary arterial hypertension using a real-world Japanese claims database.

Not Applicable

Recruiting

• Conditions: pulmonary arterial hypertension; PAH; D000081029

• Registration Number: JPRN-jRCT1010230014
• Lead Sponsor: Arai Yoko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

1. Diagnosed with PAH and prescribed PAH-targeted drug at the same calendar month in the index period, and claimed another PAH diagnosis during the period from the month following the index to the final follow-up period (with or without prescription of PAH-targeted drug)
2. Aged more than 18 years at the index date
3. At least 12 months of continuous registration before the index month (including the index month) (Baseline period)
4. At least 24 months of continuous registration after the index month (Follow-up period) (Note: For secondary objectives, change the follow-up periods to 6-month and 12 month)

Exclusion Criteria

1. Diagnosed with HIV, portal hypertension, schistosomiasis, CTEPH, or PPHN during baseline period
2. History of lung transplantation surgery during baseline period

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To understand current clinical practice and disease burden among PAH patients during 24-month follow-up period.<br>For the above purposes, we will analyze PAH patients in real-world using the JMDC claims database.<br>- Demographic and clinical characteristics at baseline<br>- Diagnosis procedure<br>- Treatment patterns<br>- Comorbidity<br>- Adherence to medication<br>- Clinical worsening<br>- HCRU and associated medical costs

Secondary Outcome Measures

Name	Time	Method
To understand current clinical practice and disease burden among PAH patients during 6- and 12-month follow-up period.<br>For the above purposes, we will analyze PAH patients in real-world.<br>- Demographic and clinical characteristics at baseline<br>- Diagnosis procedure<br>- Treatment patterns<br>- Comorbidity<br>- Adherence to medication<br>- Clinical worsening<br>- HCRU and associated medical costs