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

NCT01389271 | Completed

• 2 other identifiers: 14990VE0910TR
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary hypertension; Inhaled iloprost; Efficacy; Safety; Tolerability; Survival; NYHA class III and IV

Outcome Measures

Primary Outcomes (2)

• 6 Minutes walking distance (change in meters)

  At month 48

• Adverse events, weight, vital findings

  At month 48

Secondary Outcomes (5)

• 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

Study Arms (1)

Group 1

Drug: Ventavis inhaled (Iloprost, BAYQ6256)

Interventions

Ventavis inhaled (Iloprost, BAYQ6256) DRUG

Since this study is an observational, inhaled iloprost dosage and frequency for each patient will be prescribed by physicians as medically required.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Turkey (Türkiye)

Location

Related Links

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

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: July 8, 2011
• Study Start: February 3, 2011
• Primary Completion: March 8, 2017
• Study Completion: June 18, 2018
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

TU (1)