The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation - Bosentan therapy in Fontans

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005898-29-GB

Enrollment

Registered

2008-05-09

Start date

2008-07-04

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Patients with a Fontan circulation (that is they have had a Fontan operation for a functionally univentricular heart) MedDRA version: 9.1 Level: LLT Classification code 10045545 Term: Univentricular heart MedDRA version: 9.1 Level: LLT Classification code 10065950 Term: Cavopulmonary anastomosis MedDRA version: 9.1 Level: LLT

Interventions

Trade Name: Tracleer Product Name: bosentan Pharmaceutical Form: Tablet INN or Proposed INN: Bosentan CAS Number: 147536978

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18 or over with a Fontan circulation and NYHA II or greater symptoms of heart failure. The patient has no other significant illness that would preclude them from completing the study. Patients must be available to complete follow up. Patients must be able to provide informed consent. Patients must agree not to become pregnant during the study. 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: Lack of sinus rhythm at enrolment Permanent pacemaker in situ Inability to complete exercise testing Pre-existent liver disease as described in the bosentan SmPC1 Significant haematogical abnormality or renal dysfunction. Current use of any prostanoid, other endothelion receptor antagonist or pulmonary vasodilator therapy, such as PDE V inhibitors i.e. sildenafil or similar. Pregnancy Current enrolment in a clinical trial Any contraindication according to the bosentan SmPC1

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the safety of oral Bosentan therapy in patients with a Fontan circulation. The primary endpoint will be lack of clinically significant adverse events over the 6 month follow up period. Specifically we will look for evidence of hepatic dysfunction, haematological dysfunction and renal dysfunction. Patients will be assessed for symtomatic deterioration.;Secondary Objective: Improvement in cardiovascular performance as measured by exercise test, cardiac MRI, Borg dyspnoea index and echo.;Primary end point(s): To demonstrate the safety of oral Bosentan therapy in patients with a Fontan circulation. The primary endpoint will be lack of clinically significant adverse events over the 6 month follow up period. Specifically the study will look for evidence of hepatic dysfunction, haematological dysfunction and renal dysfunction. Patients will be assessed for symptomatic deterioration.	—

Measure

Time frame

Main Objective: To demonstrate the safety of oral Bosentan therapy in patients with a Fontan circulation. The primary endpoint will be lack of clinically significant adverse events over the 6 month follow up period. Specifically we will look for evidence of hepatic dysfunction, haematological dysfunction and renal dysfunction. Patients will be assessed for symtomatic deterioration.;Secondary Objective: Improvement in cardiovascular performance as measured by exercise test, cardiac MRI, Borg dyspnoea index and echo.;Primary end point(s): To demonstrate the safety of oral Bosentan therapy in patients with a Fontan circulation. The primary endpoint will be lack of clinically significant adverse events over the 6 month follow up period. Specifically the study will look for evidence of hepatic dysfunction, haematological dysfunction and renal dysfunction. Patients will be assessed for symptomatic deterioration.

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Countries

United Kingdom

Outcome results

None listed

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