Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)

Bayer41 enrolled

Overview

The purpose of this study is to gain information on safety and efficacy from Korean patients who starting Ventavis treatment by observational method.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pulmonary Hypertension

Interventions

Iloprost (Ventavis BAYQ6256)DRUG

Patients with pulmonary arterial hypertension, classified as New York Heart Association functional class III or IV where the treating physician has chosen Ventavis as a suitable treatment prior to inclusion into this non-interventional study. Patients should not have received prior treatment with Ventavis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The treating physician has chosen Ventavis as a suitable treatment for the patient * Patient with PH and classified as NYHA functional class III or IV and WHO group 1 Exclusion Criteria: * Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis patient package insert).

Locations (1)

Unnamed facility

Many Locations, South Korea

Outcomes

Primary Outcomes

The primary efficacy variable is 6-minute walking distance

Time frame: At baseline and month 1,3,6 for an observational period of 6 months

Secondary Outcomes

New York Heart Association functional class

Time frame: Baseline, month 1,3,6

PH-related symptoms and change of concomitant medication

Time frame: Baseline, month 1,3,6

Hemodynamic parameters

Time frame: If applicable ( at any time during Ventavis treatment)

Adverse Event collection

Time frame: If applicable (during the study period)

Data from ClinicalTrials.gov

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