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

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: Ventavis inhaled (Iloprost, BAYQ6256)

• Registration Number: NCT01389271
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-03
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-08
• Primary Completion: 2017-03-08
• Study Completion: 2018-06-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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.

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Ventavis inhaled (Iloprost, BAYQ6256)	-

Primary Outcome Measures

Name	Time	Method
6 Minutes walking distance (change in meters)	At month 48
Adverse events, weight, vital findings	At month 48

Secondary Outcome Measures

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