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Completed

NCT Number: NCT01971450

Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension

Local, prospective, multicenter, non-comparative, non-interventional, observational study. It is planed to assess compliance of patients with PH (pulmonary hypertension) with the physician's recommendation in real practice.

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Key information

Conditions

Hypertension, Pulmonary Behavior Cardiovascular Diseases Health Behavior Hypertension Lung Diseases Patient Acceptance of Health Care Patient Compliance Respiratory Tract Diseases Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Russia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients ≥ 18 years old
  • Diagnosis of PH
  • Planned or current treatment with Ventavis (not more than 6 month)

Exclusion criteria

  • Contraindications for the use of Ventavis in accordance with the local product information

Treatment and study plan

Iloprost (Ventavis, BAYQ6256)

Drug

Primary outcomes

  1. Number of days without any drug administration at all

    Time frame: Up to 12 months

  2. Number of fully inhaled doses in relation to the total number of inhalations per day

    Time frame: Up to 12 months

  3. Number of missed doses per day as recommended

    Time frame: Up to 12 months

  4. Number of actually inhaled doses per day vs. the recommended number of inhalations - either as recommended by the treating physician or as recommended by the label

    Time frame: Up to 12 months

Secondary outcomes

  1. 6 minute walking distance test (MWDT) value

    Time frame: Up to 12 months

  2. Score on dyspnea Borg CR (category ratio) 10 scale

    Time frame: Up to 12 months

  3. Patients' quality of life, assessed by validated questionnaire

    Time frame: Up to 12 months

  4. Assessment of the structural changes in the lungs using X-ray examination of the lungs

    Time frame: Up to 12 months

  5. Assessment of the structural changes in the lungs using spirography

    Time frame: Up to 12 months

  6. Assessment of lung haemodynamics using the data of echocardiography

    Time frame: Up to 12 months

  7. Assessment of lung haemodynamics using the data of catheterization

    Time frame: Up to 12 months

  8. Reason for omission of inhalation as assessed by the physician

    Time frame: Up to 12 months

  9. Concomitant medication for other indications than pulmonary hypertension

    Time frame: Up to 12 months

  10. Number of participants with adverse events (AEs)

    Time frame: Up to 12 months

  11. Severity of AEs

    Time frame: Up to 12 months

  12. AE relation to treatment

    Time frame: Up to 12 months

  13. AE treatment

    Time frame: Up to 12 months

  14. AE outcomes

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Prospective Multicentre Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension

Acronym: IVENT

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Oct 29, 2013
Registry last updated
Mar 26, 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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