Hypertension, Pulmonary
Conditions
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.
Interventions
DRUGRiociguat (Adempas, BAY63-2521)
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)
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 4 years | NYHA/ WHO: New York Heart Association / World Health Organization |
| Borg Dyspnoea Index | Up to 4 years | — |
| EQ5D visual analogue scale (VAS) score | Up to 4 years | EQ5D: EurQuol 5 dimensions (questionnaire) |
| Number of patients with hemodynamic measurements | Up to 4 years | — |
| 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 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 | — |
| Concentration of biomarkers for heart insufficiency (Brain Natriuretic Peptide (BNP) and N-Terminal pro BNP (NTpro BNP)) | 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 | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Colombia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Outcome results
None listed