EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

N/ACompletedNCT02092818

Bayer1,316 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,316

Conditions

Hypertension, Pulmonary

Interventions

Riociguat (Adempas, BAY63-2521)DRUG

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)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (28)

Unnamed facility

Multiple Locations, Argentina

Unnamed facility

Multiple Locations, Australia

Outcomes

Primary Outcomes

Number of adverse events

Time frame: Up to 4 years

Number of serious adverse events

Time frame: Up to 4 years

All-cause mortality

Time frame: Up to 4 years

Secondary Outcomes

Number of adverse event (AE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH)

Time frame: Up to 4 years

Number of serious adverse event (SAE) in different PH indications (PAH and CTEPH)

Time frame: Up to 4 years

Incidence of AE of special interest overall

Time frame: Up to 4 years

Incidence of AE of special interest in different PH indications (PAH, CTEPH)

Time frame: Up to 4 years

6 minute walking distance

Time frame: Up to 4 years

Functional class of pulmonary hypertension according to NYHA/ WHO

NYHA/ WHO: New York Heart Association / World Health Organization

Time frame: Up to 4 years

Borg Dyspnoea Index

Time frame: Up to 4 years

EQ5D visual analogue scale (VAS) score

EQ5D: EurQuol 5 dimensions (questionnaire)

Data from ClinicalTrials.gov

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