Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004705-26-GB

Enrollment

Registered

2007-04-17

Start date

2007-05-10

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eisenmenger Syndrome (pulmonary hypertension due to congenital heart disease) MedDRA version: 8.1 Level: LLT Classification code 10058554 Term: Eisenmenger's syndrome

Interventions

Trade Name: Revatio ® 20 mg film-coated tablets Product Name: Sildenafil Pharmaceutical Form: Tablet INN or Proposed INN: Sildenafil (REVATIO) CAS Number: 139755832 Current Sponsor code: cro529 Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

Exclusion criteria: 1. Patients with left ventricular dysfunction (ejection fraction 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

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026