Clinical trial NCT01389271: Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years
Official title: Open-label, Uncontrolled, Prospective Long-term Observation of Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: Pulmonary hypertension
Inhaled iloprost
Efficacy
Safety
Tolerability
Survival
NYHA class III and IV
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-07-08
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: 6 Minutes walking distance (change in meters)
timeFrame: At month 48
measure: Adverse events, weight, vital findings
timeFrame: At month 48
Secondary outcomes:
measure: 6 Minutes walking distance (% change)
timeFrame: At month 48
measure: New York Heart Association Functional Class
timeFrame: At month 48
measure: Change in drug dosage or frequency, need for PAH specific drug combination, need for drug change
timeFrame: At month 48
measure: Pulmonary hypertension related hospitalization
timeFrame: At month 48
measure: Heart and/or lung transplantation, mortality
timeFrame: At month 48
Other outcomes:
Locations:
city: Multiple Locations
country: Turkey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: