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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-03

Study Completion Date

2018-06-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Ventavis inhaled (Iloprost, BAYQ6256)

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No