EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

Completed

• Conditions: Hypertension, Pulmonary
• Interventions: Drug: Riociguat (Adempas, BAY63-2521)

• Registration Number: NCT02092818
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-19
• Study First Posted: 2014-03-20
• Study Start: 2014-05-31
• Primary Completion: 2018-03-31
• Study Completion: 2018-06-29
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1316

Inclusion Criteria

• Female and male patients who start or are on treatment with Adempas
• Written informed consent

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Exclusion Criteria

• Patients currently participating in an interventional clinical trial

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Riociguat (Adempas, BAY63-2521)	Patients who have been prescribed Adempas for a medically appropriate use

Primary Outcome Measures

Name	Time	Method
All-cause mortality	Up to 4 years
Number of adverse events	Up to 4 years
Number of serious adverse events	Up to 4 years

Secondary Outcome Measures

Name	Time	Method
Number of serious adverse event (SAE) in different PH indications (PAH and CTEPH)	Up to 4 years
Incidence of AE of special interest in different PH indications (PAH, CTEPH)	Up to 4 years
Number of days in rehabilitation	Up to 4 years
Number of days in nursery home	Up to 4 years
EQ5D visual analogue scale (VAS) score	Up to 4 years	EQ5D: EurQuol 5 dimensions (questionnaire)
Number of outpatient visits	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
Incidence of AE of special interest overall	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
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
Number of days in home care	Up to 4 years
Drug treatment for PH	Up to 4 years
Borg Dyspnoea Index	Up to 4 years
Number of hospitalization	Up to 4 years
Number of patients with hemodynamic measurements	Up to 4 years