Clinical trial NCT02092818: EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension
Official title: EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-03-20
Enrollment: 1316
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have been prescribed Adempas® for a medically appropriate use

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.


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

Primary outcomes:
measure: Number of adverse events
timeFrame: Up to 4 years
measure: Number of serious adverse events
timeFrame: Up to 4 years
measure: All-cause mortality
timeFrame: Up to 4 years
Secondary outcomes:
measure: Number of adverse event (AE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH)
timeFrame: Up to 4 years
measure: Number of serious adverse event (SAE) in different PH indications (PAH and CTEPH)
timeFrame: Up to 4 years
measure: Incidence of AE of special interest overall
timeFrame: Up to 4 years
measure: Incidence of AE of special interest in different PH indications (PAH, CTEPH)
timeFrame: Up to 4 years
measure: 6 minute walking distance
timeFrame: Up to 4 years
measure: Functional class of pulmonary hypertension according to NYHA/ WHO
timeFrame: Up to 4 years
measure: Borg Dyspnoea Index
timeFrame: Up to 4 years
measure: EQ5D visual analogue scale (VAS) score
timeFrame: Up to 4 years
measure: Number of patients with hemodynamic measurements
timeFrame: Up to 4 years
measure: Concentration of biomarkers for heart insufficiency (Brain Natriuretic Peptide (BNP) and N-Terminal pro BNP (NTpro BNP))
timeFrame: Up to 4 years
measure: Number of hospitalization
timeFrame: Up to 4 years
measure: Number of outpatient visits
timeFrame: Up to 4 years
measure: Number of days in home care
timeFrame: Up to 4 years
measure: Number of days in rehabilitation
timeFrame: Up to 4 years
measure: Number of days in nursery home
timeFrame: Up to 4 years
measure: Drug treatment for PH
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Multiple Locations
country: Argentina
city: Multiple Locations
country: Australia
city: Multiple Locations
country: Austria
city: Multiple Locations
country: Belgium
city: Multiple Locations
country: Canada
city: Multiple Locations
country: Colombia
city: Multiple Locations
country: Czechia
city: Multiple Locations
country: Denmark
city: Multiple Locations
country: Estonia
city: Multiple Locations
country: Finland
city: Multiple Locations
country: France
city: Multiple Locations
country: Germany
city: Multiple Locations
country: Greece
city: Multiple Locations
country: Ireland
city: Multiple Locations
country: Italy
city: Multiple Locations
country: Luxembourg
city: Multiple Locations
country: Netherlands
city: Multiple Locations
country: Norway
city: Multiple Locations
country: Portugal
city: Multiple Locations
country: Russian Federation
city: Multiple Locations
country: Saudi Arabia
city: Multiple Locations
country: Slovakia
city: Multiple Locations
country: Spain
city: Multiple Locations
country: Sweden
city: Multiple Locations
country: Switzerland
city: Multiple Locations
country: Taiwan
city: Multiple Locations
country: Turkey
city: Multiple Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: