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

Phase 1

• Conditions: Pulmonary Arterial Hypertension Eisenmenger syndrome; MedDRA version: 17.0Level: LLTClassification code 10037405Term: Pulmonary hypertension primarySystem Organ Class: 100000004855; MedDRA version: 17.0Level: LLTClassification code 10037406Term: Pulmonary hypertension secondarySystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-000091-25-GB
• Lead Sponsor: Royal Brompton and Harefield NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-11
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• 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 6-minute 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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

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 clinical trial of medicinal product
• Study Design: Not specified