Pulmonary Arterial Hypertension Eisenmenger syndrome MedDRA version: 17.0 Level: LLT Classification code 10037405 Term: Pulmonary hypertension primary System Organ Class: 100000004855 MedDRA version: 17.0 Level: LLT Classification code 10037406 Term: Pulmonary hypertension secondary System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Iloprost
Product Name: Ventavis
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: Iloprost
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: up to
Concentra
Sponsors
Royal Brompton and Harefield NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Patients > 18 years 2. Body weight > 40 kg 3. Functional class III (1998 WHO classification) 4. Patients with documented oxygen saturation =65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the impact of iloprost - an inhaled pulmonary vasodilator (opens up the blood vessels in the lung)- on exercise capacity in patients with the congenital heart condition Eisenmenger Syndrome. ;Secondary Objective: To assess the impact of iloprost on quality of life, oxygen levels in the blood (saturations), blood markers of “heart strain” (brain natriuretic peptide (bnp)) and heart function, as determined by an echocardiograph (ultrasound of the heart).;Primary end point(s): To assess the impact of Iloprost on exercise performance for a 6 Minute Walk Test (6MWT). ;Timepoint(s) of evaluation of this end point: Once patients have consented to the study they will be admitted for 3 days/2 nights to titrate the drug or placebo up to the maximum dose. 12 weeks later they will then return for a further 2 days/1 night to stop the medication. 1-2 weeks later the patients will return to receive the opposite solution and will be monitored again for 3 days/2 night and at the end of the following 12 weeks stay for 2 days/1 night. There will be 4 time points during the study when the patient is monitored. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the impact of Iloprost on haemodynamic parameters, echocardiographic parameters, serum neuropeptide levels, Quality of Life (QoL), oxygen saturation at rest and on WHO functional class ;Timepoint(s) of evaluation of this end point: The participants will be evaluated at 4 time points whilst enrolled into the study. | — |
Countries
United Kingdom
Contacts
Public ContactIra Jakupovic
Royal Brompton and Harefield NHS Foundation Trust
Outcome results
None listed