Overview

This trial is active, not recruiting.

Condition pulmonary hypertension
Treatment ventavis (iloprost, bayq6256)
Sponsor Bayer
Start date September 2013
End date December 2016
Trial size 13 participants
Trial identifier NCT01894035, 16755, VE1310PT

Summary

This pilot, non-interventional, company-sponsored, multi-center study documents observational data on patients under routine treatment of Pulmonary Arterial Hypertension (PAH) with inhaled iloprost (using I-Neb device for the inhalation).

The planned study recruitment time is 18 months. The maximum follow up period in this study will be 12 months.

The data will be collected from patients who have initiated the treatment mentioned above (inhaled iloprost using I-Neb device) since February 1st, 2013.

Frequency of visits and procedures will be performed under routine conditions. The primary objective of this study is to assess the compliance of patients with WHO/NYHA (World Health Organization/New York Heart Association) functional Class III Pulmonary Arterial Hypertension treated with Inhaled Iloprost in clinical practice, using the I-neb Insight tool.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
ventavis (iloprost, bayq6256)
Patients Diagnosed with Pulmonary Arterial Hypertension, Functional Class NYHA/WHO III, for whom was prescribed inhaled Iloprost.

Primary Outcomes

Measure
Percentage of compliant patients
time frame: Up to 12 months

Secondary Outcomes

Measure
Observed treatment duration days
time frame: Up to 12 months
Expected treatment duration days
time frame: Up to 12 months
Changes in WHO/ NYHA Functional Class
time frame: Up to 12 months
Change in 6 MWDT (6 minute walking distance test) scale value
time frame: Up to 12 months
Change in Dyspnea Borg CR (category ratio) 10 scale value
time frame: Up to 12 months
Quality of life using validated scales (EuroQol questionnaire [EQ-5D], Living with Pulmonary Hypertension questionnaire [LPH])
time frame: Up to 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients (age ≥ 18years old), male or female - Diagnosis of Pulmonary Arterial Hypertension, Group I of the Dana Point Pulmonary Hypertension classification (Diagnosis made at the discretion of the attending investigator, including mPAP ≥ 25 mmHg at rest, as measured by right heart catheterization.) - The treating physician has chosen to initiate the treatment with inhaled iloprost with I-Neb device for the application, as described in the Summary of Product characteristics (SmPC). - WHO/NYHA functional class III - Willing to participate in the study (Informed Consent Sign) - Patients who received the first inhaled iloprost treatment with I-Neb from February 1st, 2013. Exclusion Criteria: - Any contraindication for the treatment with Ventavis as described in the Summary of Product characteristics (SmPC) - Patients are not to be enrolled if they were treated with inhaled iloprost with I-Neb or any other device for the application in the past, before the start of the observation period (February 1st, 2013)

Additional Information

Official title Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.