Efficacy of Ventavis Used in Real-life Setting.

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

Sponsors

Lead Sponsor: Bayer

Source Bayer
Brief Summary

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.

Overall Status Completed
Start Date August 5, 2010
Completion Date September 22, 2016
Primary Completion Date April 28, 2016
Study Type Observational
Primary Outcome
Measure Time Frame
Changes of the exercise capacity as measured by 6-minutes walking distance 3, 6, 9 and 12 months vs. baseline
Secondary Outcome
Measure Time Frame
Changes of depression score over time 3, 6, 9 and 12 months vs. baseline
Changes of functional capacity as measured by WHO classification system 3, 6, 9 and 12 months vs. baseline
Changes of pulmonary haemodynamics 3, 6, 9 and 12 months vs. baseline
Changes of serum level of natriuretic peptide B 3, 6, 9 and 12 months vs. baseline
Changes of Quality of Life score 3, 6, 9 and 12 months vs. baseline
Changes in cardiac echo parameters 3, 6, 9 and 12 months vs. baseline
Number of patients with treatment-emergent adverse events Up to 12 months
Enrollment 55
Condition
Intervention

Intervention Type: Drug

Intervention Name: Inhaled iloprost (Ventavis, BAYQ6256)

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

Arm Group Label: Group 1

Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Bayer Study Director Study Director Bayer
Location
Facility:
Location Countries

Poland

Verification Date

October 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Group 1

Description: Drug (incl. Placebo)

Acronym SPHERA
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov