Iloprost in patients with Eisenmenger syndrome
| ISRCTN | ISRCTN15915491 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15915491 |
| EudraCT/CTIS number | 2014-000091-25 |
| Secondary identifying numbers | 18181 |
- Submission date
- 04/02/2015
- Registration date
- 05/02/2015
- Last edited
- 20/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Eisenmenger's 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.
Who can participate?
Adults (aged at least 18) with Eisenmenger's Syndrome.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given iloprost . Those in group 2 are given an inhaled placebo. Each participant receives 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 “crossover” study. At the end of the study all participants are able to take iloprost indefinitely in an “openlabel” phase. During the study, participant responses such as walking distance, oxygen levels, quality of life questionnaire and heart function as determined by ultrasound (echocardiography) are monitored.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Royal Brompton Hospital (UK)
When is the study starting and how long is it expected to run for?
December 2014 to May 2016
Who is funding the study?
Bayer PLC (UK)
Who is the main contact?
Ms Natalie Dormand
Contact information
Scientific
Royal Brompton Hospital
Sydney Street
London
SW3 6NP
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | A single-centre, placebo-controlled, double-blinded, randomized, crossover study of Iloprost (Ventavis®) in patients with Eisenmenger syndrome |
| Study hypothesis | This study aims to investigate whether iloprost, an inhaled prostanoid, is beneficial in terms of exercise capacity in Eisenmenger syndrome patients who are deteriorating or have an unsatisfactory response to two oral therapies. |
| Ethics approval(s) | 14/LO/1182 |
| Condition | Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Congenital Heart Disease and Pulmonary Hypertension |
| Intervention | Use of nebulised Iloprost in addition to maximum oral pulmonary vasodilative therapy. 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 socalled “crossover” study. At the end of the study the patient will be able to take iloprost indefinitely in an “openlabel” 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). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Iloprost |
| Primary outcome measure | Change in 6 Minute Walk Test over 3 months compared with placebo |
| Secondary outcome measures | N/A |
| Overall study start date | 15/12/2014 |
| Overall study end date | 15/05/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 15; UK Sample Size: 15 |
| Participant inclusion criteria | 1. Patients > 18 years 2. Body weight > 40 kg 3. Functional class III (1998 WHO classification) 4. Patients with documented oxygen saturation < 90%, at rest or during exercise with room air 5. Patients with established pulmonary hypertension related to congenital heart disease and post – tricuspid lesion able to perform a 6minute walk test with latest walking distance < 400m or deterioration of 30m within 1 Year on dual oral therapy or patient not tolerating oral therapy 6. Patients stable for at least 3 months prior to screening 7. Patients providing written informed consent |
| Participant exclusion criteria | 1. Pregnant patients 2. Trisomy 21 3. Obstructive lung disease (FEV1/FVC<60%) 4. Patients with systolic blood pressure <90 mm Hg 5. Patients with other conditions that may affect the ability to perform a six minute walk test 6. Patients unable to provide informed consent and comply with the protocol 7. Patients with known coronary artery disease 8. Patients who have started or stopped specific treatment for PAH within one month of screening, excluding anticoagulation 9. Patients active on an organ transplant list 10.Patients taking other investigational drugs/devices 11. Patients taking other Prostacyclin analogues, like Epoprostenol or Treprostinil 12. Patients with planned surgical intervention during the study period 13. Patients with HIV |
| Recruitment start date | 15/12/2014 |
| Recruitment end date | 15/05/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW3 6NP
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Brompton Hospital
Sydney Street
London
SW3 6NP
England
United Kingdom
"ROR" |
https://ror.org/02218z997 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 11/02/2021 | 20/05/2022 | No | No | |
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
20/05/2022: EU Clinical Trials Register results added.
06/06/2018: No publications found, verifying study status with principal investigator.
