Clinical trial NCT02117791: Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH )
Official title: Drug Use Investigation of Riociguat for ChronicThromboembolic Pulmonary Hypertension (CTEPH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Keywords: Riociguat, Adempas, sGC stimulator, CTEPH, Japan, PMS
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 1298
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes patients treated with Riociguat for inoperable CTEPH/ persistent or recurrent CTEPH after surgical treatment. This study is performed as an all-case investigation. Therefore, all patients who have been treated with Riociguat for CTEPH need to be registered in principle, until the target number of patients reached.

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.


Eligibility criteria: Inclusion Criteria:

* Patients who are treated with Riociguat for CTEPH

Exclusion Criteria:

* Patients who are contraindicated based on the product label

Primary outcomes:
measure: Number of participants with treatment emergent adverse events and adverse drug reactions
timeFrame: up to 8 years
Secondary outcomes:
measure: Change from baseline in 6MWD (6-Minute Walking Distance) after 4 and 12 months
timeFrame: baseline and 4 months, and 12 months
measure: Change from baseline in Pulmonary Vascular Resistance (PVR) after 4 and 12 months
timeFrame: baseline and 4 months, and 12 months
measure: Change from baseline in TRPG (Tricuspid Regurgitation Pressure Gradient) after 4 and 12 months
timeFrame: baseline and 4 months, and 12 months
measure: Change from baseline in BNP/NT-pro BNP after 4 and 12 months
timeFrame: baseline and 4 months, and 12 months
measure: Change from baseline in WHO (World Health Organization) functional class after 4 and 12 months
timeFrame: baseline and 4 months, and 12 months
measure: Time to Clinical Worsening
timeFrame: up to 8 years
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Tanabe N, Ogo T, Hatano M, Kigawa A, Sunaya T, Sato S. Safety and effectiveness of riociguat for chronic thromboembolic pulmonary hypertension in real-world clinical practice: interim data from post-marketing surveillance in Japan. Pulm Circ. 2020 Jul 23;10(3):2045894020938986. doi: 10.1177/2045894020938986. eCollection 2020 Jul-Sep.