JPMS-CTEPH: Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH )
Study Details
Study Description
Brief Summary
This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/ persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of 400 patients (valid for safety analysis). This study is performed as an all-case investigation. The treatment of Riociguat is performed based on the product label in Japan. The standard observation period is 12 months from the 1st treatment of Riociguat. Safety and effectiveness are evaluated at 4th and 12th month. In addition, the extension observation is carried out once a year for 7 years at the longest to collect information on safety and effectiveness as long as Riociguat treatment continues. When the treatment of Riociguat is terminated, observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using the Electronic Data Capture (EDC) system. The duration of the study is approximately 9 years from launch.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1 Riociguat treatment group |
Drug: Riociguat (ADEMPAS, BAY63-2521)
The treatment of Riociguat should comply with the local product information (start dose: 3 mg/day, maximum dose: 7.5 mg/day)
|
Outcome Measures
Primary Outcome Measures
- Number of participants with treatment emergent adverse events and adverse drug reactions [up to 8 years]
Secondary Outcome Measures
- Change from baseline in 6MWD (6-Minute Walking Distance) after 4 and 12 months [baseline and 4 months, and 12 months]
- Change from baseline in Pulmonary Vascular Resistance (PVR) after 4 and 12 months [baseline and 4 months, and 12 months]
- Change from baseline in TRPG (Tricuspid Regurgitation Pressure Gradient) after 4 and 12 months [baseline and 4 months, and 12 months]
- Change from baseline in BNP/NT-pro BNP after 4 and 12 months [baseline and 4 months, and 12 months]
- Change from baseline in WHO (World Health Organization) functional class after 4 and 12 months [baseline and 4 months, and 12 months]
- Time to Clinical Worsening [up to 8 years]
The first occurrence of the following events is recorded and will be considered for the calculation of the combined endpoint: • Death (all-cause mortality) • Heart/lung transplantation • Rescue Pulmonary Endarterectomy, Rescue Balloon Pulmonary Angioplasty or Hospitalization due to persistent worsening of Pulmonary Hypertension • Start of new PH specific treatment due to worsening Pulmonary Hypertension. • Persistent decrease in 6MWD due to worsening pulmonary hypertension • Persistent worsening of functional class due to deterioration of Pulmonary Hypertension.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients who are treated with Riociguat for CTEPH
Exclusion Criteria:
- Patients who are contraindicated based on the product label
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Multiple Locations | Japan |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16843
- ADEMPAS-CTEPH