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

JRCT ID: jRCT1010230014

Registered date:01/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pulmonary arterial hypertension
• Date of first enrollment: 01/07/2023
• Target sample size: 312
• Study type: Observational

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude criteria

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

Related Information

• Primary Sponsor: Arai Yoko