EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.

Official Title
-----------------
EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

Conditions
-----------------
Hypertension, Pulmonary

Intervention / Treatment
-----------------
* Drug: Riociguat (Adempas, BAY63-2521)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male patients who start or are on treatment with Adempas Written informed consent Exclusion Criteria: Patients currently participating in an interventional clinical trial
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients who have been prescribed Adempas for a medically appropriate use | Drug: Riociguat (Adempas, BAY63-2521)<br>* The decision on clinical management of the patient including the actual treatment duration will be determined solely by the physician not by the clinical study protocol (CSP)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | Up to 4 years | 
| Number of serious adverse events |  | Up to 4 years | 
| All-cause mortality |  | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse event (AE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH) |  | Up to 4 years | 
| Number of serious adverse event (SAE) in different PH indications (PAH and CTEPH) |  | Up to 4 years | 
| Incidence of AE of special interest overall |  | Up to 4 years | 
| Incidence of AE of special interest in different PH indications (PAH, CTEPH) |  | Up to 4 years | 
| 6 minute walking distance |  | Up to 4 years | 
| Functional class of pulmonary hypertension according to NYHA/ WHO | NYHA/ WHO: New York Heart Association / World Health Organization | Up to 4 years | 
| Borg Dyspnoea Index |  | Up to 4 years | 
| EQ5D visual analogue scale (VAS) score | EQ5D: EurQuol 5 dimensions (questionnaire) | Up to 4 years | 
| Number of patients with hemodynamic measurements |  | Up to 4 years | 
| Concentration of biomarkers for heart insufficiency (Brain Natriuretic Peptide (BNP) and N-Terminal pro BNP (NTpro BNP)) |  | Up to 4 years | 
| Number of hospitalization |  | Up to 4 years | 
| Number of outpatient visits |  | Up to 4 years | 
| Number of days in home care |  | Up to 4 years | 
| Number of days in rehabilitation |  | Up to 4 years | 
| Number of days in nursery home |  | Up to 4 years | 
| Drug treatment for PH |  | Up to 4 years |