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Iloprost in patients with Eisenmenger Syndrome

  • Research type

    Research Study

  • Full title

    A single-centre, placebo-controlled, double-blinded, randomized, cross-over study of Iloprost (Ventavis®) in patients with Eisenmenger syndrome

  • IRAS ID

    121948

  • Contact name

    Gatzoulis Michael

  • Contact email

    m.gatzoulis@rbht.nhs.uk

  • Sponsor organisation

    Royal Brompton and Harefield NHS Foundation Trust

  • Eudract number

    2014-000091-25

  • Research summary

    Eisenmenger Syndrome is a congenital condition affecting the heart which results in low oxygen levels in the blood and high blood pressure within the lungs. The increase in blood pressure is caused by thickening and narrowing of the blood vessels in the lung. Currently, treatment includes relatively new medications called “advanced therapies”, which are “pulmonary vasodilators”; this means that they open up the blood vessels and help blood flow through the lungs and improve the function of the heart. These medications have been shown to improve patients’ symptoms and also length of life. These treatments are expensive and are tightly regulated. At present, the Commissioners allow us to treat patients with up to two types of pulmonary vasodilators; normally both tablets. A third class of medication are the “prostanoids”. These are unstable medicines which need to be given regularly, either as a nebuliser (inhaled) or intravenously. At present, although licensed for use in Eisenmenger syndrome, we are not allowed to prescribe such medicines on top of two tablets. This study aims to investigate whether iloprost, an inhaled prostanoid, is beneficial in terms of exercise capacity in patients who are deteriorating or have an unsatisfactory response to two oral therapies. The study will involve patients receiving either iloprost or an inhaled placebo; both doctors and patients will be “blinded” to what they are receiving. The patient will receive one study drug for 12 weeks, have a 1 week “washout” and then take the other medication for a further 12 weeks, in a so-called “cross-over” study. At the end of the study the patient will be able to take iloprost indefinitely in an “open-label” phase. During the study we will monitor responses such as walking distance, oxygen levels, quality of life questionnaire and heart function as determined by ultrasound (echocardiography).

  • REC name

    London - City & East Research Ethics Committee

  • REC reference

    14/LO/1182

  • Date of REC Opinion

    26 Aug 2014

  • REC opinion

    Further Information Favourable Opinion