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OpenTrials
Completed

NCT Number: NCT01355380

Efficacy of Ventavis Used in Real-life Setting.

This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.

Typical clinical measures and quality of life will be prospectively followed in 12 months period.

Completed

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Poland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pulmonary arterial hypertension in WHO functional class III or IV
  • Age 18+
  • Patients newly treated with Ventavis or switched from sildenafil

Exclusion criteria

  • Retrospective documentation is not allowed

Treatment and study plan

Inhaled iloprost (Ventavis, BAYQ6256)

Drug

Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily

Primary outcomes

  1. Changes of the exercise capacity as measured by 6-minutes walking distance

    Time frame: 3, 6, 9 and 12 months vs. baseline

Secondary outcomes

  1. Changes of depression score over time

    Time frame: 3, 6, 9 and 12 months vs. baseline

  2. Changes of functional capacity as measured by WHO classification system

    Time frame: 3, 6, 9 and 12 months vs. baseline

  3. Changes of pulmonary haemodynamics

    Time frame: 3, 6, 9 and 12 months vs. baseline

  4. Changes of serum level of natriuretic peptide B

    Time frame: 3, 6, 9 and 12 months vs. baseline

  5. Changes of Quality of Life score

    Time frame: 3, 6, 9 and 12 months vs. baseline

  6. Changes in cardiac echo parameters

    Time frame: 3, 6, 9 and 12 months vs. baseline

  7. Number of patients with treatment-emergent adverse events

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

The Efficacy of Inhaled Iloprost in Patients Treated Within the "Pulmonary Arterial Hypertension Therapeutic Programme".

Acronym: SPHERA

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
May 18, 2011
Registry last updated
Oct 17, 2017

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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