Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology

Phase 1

• Conditions: Eisenmenger Syndrome (pulmonary hypertension due to congenital heart disease); MedDRA version: 8.1Level: LLTClassification code 10058554Term: Eisenmenger's syndrome

• Registration Number: EUCTR2006-004705-26-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-17
• Study Completion: 2009-02-27
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Patients >18 years with a functional class III (1998 WHO classification).
2. Patients with pulmonary arterial hypertension related to Eisenmenger physiology
3. Patients with documented oxygen saturation <90%, and >70% (at rest, with room air).
4. Patients stable for at least 3 months prior to screening.
5. Patients providing written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with left ventricular dysfunction (ejection fraction <40%).
2. Patients with systolic blood pressure < 85 mm Hg.
3. Patients with other conditions that may affect the ability to perform a 6-minute walk test.
4. Patients unable to provide informed consent and comply with the patient protocol.
5. Patients with known coronary arterial disease.
6. Patients with serum creatinine >125 µM/l.
6. Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted).
7. Patients who have started or stopped treatment for PAH within one month of screening, excluding anticoagulation.
8. Patients who are receiving vasodilators including, but not limited to epoprostenol or prostacyclin analogues, or are expected to receive any of these drugs during the study.
9. Patients active on organ transplant lists.
10. Patients taking phosphodiesterase inhibitors, nitrates or endothelin receptor antagonists
11. Patients with planned surgical intervention during the study period.
15. Pregnant patients
16. Patients treated with potent CYP3A4 inhibitors

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine safety and tolerability of oral sildenafil in patients with Eisenmenger physiology. <br><br>Primary endpoint:<br>Effects of sildenafil on systemic oxygen saturation in patients with pulmonary arterial hypertension related to Eisenmenger physiology<br>;Secondary Objective: To evaluate the effects of sildenafil on <br>- WHO functional class <br>- 6 minute walk test<br>- Dyspnea (Borg Index)<br>- Pulmonary perfusion (using respiratory mass spectrometry)<br>- Quality of life<br>- Overall safety and tolerability;Primary end point(s): Effects of sildenafil on systemic oxygen saturation (%) in patients with pulmonary arterial hypertension related to Eisenmenger physiology.