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OpenTrials
Completed

NCT Number: NCT02092818

EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

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.

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Number of adverse events

    Time frame: Up to 4 years

  2. Number of serious adverse events

    Time frame: Up to 4 years

  3. All-cause mortality

    Time frame: Up to 4 years

Secondary outcomes

  1. 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

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

    Time frame: Up to 4 years

  3. Incidence of AE of special interest overall

    Time frame: Up to 4 years

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

    Time frame: Up to 4 years

  5. 6 minute walking distance

    Time frame: Up to 4 years

  6. Functional class of pulmonary hypertension according to NYHA/ WHO

    Time frame: Up to 4 years

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

  7. Borg Dyspnoea Index

    Time frame: Up to 4 years

  8. EQ5D visual analogue scale (VAS) score

    Time frame: Up to 4 years

    EQ5D: EurQuol 5 dimensions (questionnaire)

  9. Number of patients with hemodynamic measurements

    Time frame: Up to 4 years

  10. Concentration of biomarkers for heart insufficiency (Brain Natriuretic Peptide (BNP) and N-Terminal pro BNP (NTpro BNP))

    Time frame: Up to 4 years

  11. Number of hospitalization

    Time frame: Up to 4 years

  12. Number of outpatient visits

    Time frame: Up to 4 years

  13. Number of days in home care

    Time frame: Up to 4 years

  14. Number of days in rehabilitation

    Time frame: Up to 4 years

  15. Number of days in nursery home

    Time frame: Up to 4 years

  16. Drug treatment for PH

    Time frame: Up to 4 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: EXPERT

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 20, 2014
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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