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

Prospective Multicentre 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.

Study Overview

• Status: Completed
• Conditions: Hypertension, Pulmonary
• Intervention / Treatment: Drug: Iloprost (Ventavis, BAYQ6256)

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• Russian Federation
  • Multiple Locations, Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients ≥ 18 years old with PH, treated with Ventavis and for which the inclusion and exclusion criteria are fulfilled, are eligible for enrolment into the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Iloprost; The patients with pulmonary hypertension with inhaled treatment with Ventavis according to routine practice meeting the criteria of inclusion.	Drug: Iloprost (Ventavis, BAYQ6256)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of days without any drug administration at all	Up to 12 months
Number of fully inhaled doses in relation to the total number of inhalations per day	Up to 12 months
Number of missed doses per day as recommended	Up to 12 months
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	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
6 minute walking distance test (MWDT) value	Up to 12 months
Score on dyspnea Borg CR (category ratio) 10 scale	Up to 12 months
Patients' quality of life, assessed by validated questionnaire	Up to 12 months
Assessment of the structural changes in the lungs using X-ray examination of the lungs	Up to 12 months
Assessment of the structural changes in the lungs using spirography	Up to 12 months
Assessment of lung haemodynamics using the data of echocardiography	Up to 12 months
Assessment of lung haemodynamics using the data of catheterization	Up to 12 months
Reason for omission of inhalation as assessed by the physician	Up to 12 months
Concomitant medication for other indications than pulmonary hypertension	Up to 12 months
Number of participants with adverse events (AEs)	Up to 12 months
Severity of AEs	Up to 12 months
AE relation to treatment	Up to 12 months
AE treatment	Up to 12 months
AE outcomes	Up to 12 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2013
• Primary Completion (Actual): June 28, 2017
• Study Completion (Actual): April 18, 2018

Study Registration Dates

• First Submitted: September 20, 2013
• First Submitted That Met QC Criteria: October 24, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Iloprost; Pulmonary hypertension; Compliance; Non-interventional; Russian Federation; Ventavis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Vasodilator Agents; Platelet Aggregation Inhibitors; Iloprost
• Other Study ID Numbers: 16777; VE1311RU (Other Identifier: Company internal)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No