Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years (OPTION)

Open-label, Uncontrolled, Prospective Long-term Observation of Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years

This is an open-label, uncontrolled, prospective long-term observation of Specific Drug in the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV planned to enroll. Efficacy, safety and tolerability of the drug and the survival of the patients will be observed.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• Turkey
  • Multiple Locations, Turkey

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: Probability Sample

Study Population

Primary (idiopathic and familial) pulmonary hypertension and PAH secondary to scleroderma without significant interstitial pulmonary disease classified as New York Heart Association (NYHA) functional class III and IV

Description

Inclusion Criteria:

• Patients who has pulmonary hypertension treated with inhaled iloprost older than 18 years old.
• Primary (idiopathic and familial) pulmonary hypertension (PH) with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
• Pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
• Patients who signed written informed consent.

Exclusion Criteria:

• Severe coronary heart disease or unstable angina; Myocardial infarction within the last six months; Decompensated cardiac failure if not under close medical supervision;
• Severe arrhythmias;
• Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
• Pulmonary hypertension due to venous occlusive disease.
• Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
• Pregnancy and lactation
• Age below 18

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: Ventavis inhaled (Iloprost, BAYQ6256); Since this study is an observational, inhaled iloprost dosage and frequency for each patient will be prescribed by physicians as medically required.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
6 Minutes walking distance (change in meters)	At month 48
Adverse events, weight, vital findings	At month 48

Secondary Outcome Measures

Outcome Measure	Time Frame
6 Minutes walking distance (% change)	At month 48
New York Heart Association Functional Class	At month 48
Change in drug dosage or frequency, need for PAH specific drug combination, need for drug change	At month 48
Pulmonary hypertension related hospitalization	At month 48
Heart and/or lung transplantation, mortality	At month 48

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): February 3, 2011
• Primary Completion (Actual): March 8, 2017
• Study Completion (Actual): June 18, 2018

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Survival; Efficacy; Pulmonary hypertension; Tolerability; Inhaled iloprost; NYHA class III and IV
• 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: 14990; VE0910TR (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
• product manufactured in and exported from the U.S.: No