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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	25 November 2019
Main ID:	EUCTR2005-005898-29-GB
Date of registration:	09/05/2008
Prospective Registration:	Yes
Primary sponsor:	University Hospital Birmingham
Public title:	The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation - Bosentan therapy in Fontans
Scientific title:	The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation - Bosentan therapy in Fontans
Date of first enrolment:	04/07/2008
Target sample size:	15
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005898-29
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
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Affiliation:

Name:
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Key inclusion & exclusion 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:
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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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 Classification code 10037456 Term: Pulmonary vascular resistance abnormality

Intervention(s)

Trade Name: Tracleer
Product Name: bosentan
Pharmaceutical Form: Tablet
INN or Proposed INN: Bosentan
CAS Number: 147536978
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 62.5-
INN or Proposed INN: Bosentan
CAS Number: 147536978
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-

Primary Outcome(s)

Secondary Objective: Improvement in cardiovascular performance as measured by exercise test, cardiac MRI, Borg dyspnoea index and echo.

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.

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.

Secondary Outcome(s)

Secondary ID(s)

RRK2962

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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