Iloprost in patients with Eisenmenger syndrome

Not Applicable

Completed

• Conditions: Subtopic: Cardiovascular (all Subtopics); Circulatory System; Topic: Cardiovascular disease; Disease: Congenital Heart Disease and Pulmonary Hypertension

• Registration Number: ISRCTN15915491
• Lead Sponsor: Royal Brompton & Harefield NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-05
• Study Completion: 2016-05-15
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in 6 Minute Walk Test over 3 months compared with placebo