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OpenTrials
Completed

NCT Number: NCT01389271

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

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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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 6 Minutes walking distance (change in meters)

    Time frame: At month 48

  2. Adverse events, weight, vital findings

    Time frame: At month 48

Secondary outcomes

  1. 6 Minutes walking distance (% change)

    Time frame: At month 48

  2. New York Heart Association Functional Class

    Time frame: At month 48

  3. Change in drug dosage or frequency, need for PAH specific drug combination, need for drug change

    Time frame: At month 48

  4. Pulmonary hypertension related hospitalization

    Time frame: At month 48

  5. Heart and/or lung transplantation, mortality

    Time frame: At month 48

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Open-label, Uncontrolled, Prospective Long-term Observation of Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years

Acronym: OPTION

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Jul 8, 2011
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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