Ventavis® Registry Protocol
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Registration Number
- NCT00902603
- Lead Sponsor
- Actelion
- Brief Summary
The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. Data will be collected via patient interview and review of the medical record. Quarterly data collection will include capture of medications and Ventavis® adherence data.
- Detailed Description
The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH and who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. All data will be collected via patient interview and/or review of the medical record, as well as from I-neb® downloads using INSIGHT software. Adherence with Ventavis® will be compared before and after targeted instruction on inhalation techniques by a respiratory therapist or designee, as well as before and after participation in PAH patient support groups (if applicable). Quarterly data collection will include capture of PAH and non-PAH medications and Ventavis® adherence data; Ventavis® adherence data will also be collected one month after study entry.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 148
- Have a current diagnosis of WHO Group I PAH
- Have initiated therapy with commercial Ventavis® administered via portable nebulizer at least 3 months prior to study enrollment, either with commercial product or from participation in Actelion's Clinical Study AC-063A302
- Age > or = 18 years old at the time of enrollment
- Meet the criteria for inclusion into WHO Groups II, III, IV or V PAH
- Are not currently on commercial Ventavis®
- Have initiated therapy with commercial Ventavis® administered via portable nebulizer less than 3 months prior to study enrollment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Commercial Ventavis® (iloprost) Patients with WHO Group I pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months.
- Primary Outcome Measures
Name Time Method Adherence with instructions for use of Ventavis® 2 years
- Secondary Outcome Measures
Name Time Method Persistence of use of Ventavis® 2 years
Trial Locations
- Locations (31)
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
Cleveland Cliic Florida
🇺🇸Weston, Florida, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Orlando Heart Center
🇺🇸Orlando, Florida, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Western States Clinical Research
🇺🇸Wheatridge, Colorado, United States
Kentuckiana Pulmonary Associates
🇺🇸Louisville, Kentucky, United States
Nebraska Pulmonary Specialties
🇺🇸Lincoln, Nebraska, United States
St. Louis University
🇺🇸St. Louis, Missouri, United States
Sierra Nevada Cardiology Associates
🇺🇸Reno, Nevada, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Kaleida Health/Buffalo General Hospital
🇺🇸Buffalo, New York, United States
Pulmonary Health Physicians
🇺🇸Syracuse, New York, United States
North Shore University - LIJ Medical Center
🇺🇸New Hyde Park, New York, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Baylore College of Medicine
🇺🇸Houston, Texas, United States
Central Utah Clinic
🇺🇸Provo, Utah, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
UCSF Fresno
🇺🇸Fresno, California, United States
UCLA
🇺🇸Los Angeles, California, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
UCSD Medical Center
🇺🇸La Jolla, California, United States
Central Florida Pulmonary Group
🇺🇸Orlando, Florida, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States