|
Main
|
|
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:
|
19 March 2012 |
|
Main ID: |
EUCTR2008-004533-21-NL |
|
Date of registration:
|
14/11/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
The role of Bosentan in fontan patients: improvement of aerobic capacity - bosentan in fontan patients
|
|
Scientific title:
|
The role of Bosentan in fontan patients: improvement of aerobic capacity - bosentan in fontan patients |
|
Date of first enrolment:
|
25/06/2010 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004533-21 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: no bosentan
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
All adult Fontan patients are potentially eligible for this study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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:
Patients are not eligible for this study if the following inclusion criteria apply:
- Systemic arterial pressure < 85 mmHg
- Incapable of giving informed consent
- Hypersensitivity to bosentan or any of its help substances
- Current treatment with bosentan or treatment for pulmonary arterial hypertension
- Moderate to severe liver disease: Child-Pugh class B or C
- Raised plasma transaminases level > three times limiting value.
- Simultaneous use of cyclosporine A
- Pregnant or nursing women (a pregnancy test is offered to every female patient within the fertile age)
- Desire to have children within the study period or women who do not use reliable contraceptive methods
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
To study whether bosentan (endothelin receptor inhibitor) improves aerobic capacity (VO2max) and exercise performance in adult patients with a Fontan operation.
MedDRA version: 9.1
Level: LLT
Classification code 10064911
Term: Pulmonary arterial hypertension
|
|
Intervention(s)
|
Trade Name: Tracleer
Product Name: Tracleer
Product Code: 66215-101
Pharmaceutical Form: Coated tablet
INN or Proposed INN: BOSENTAN
CAS Number: 147536978
Current Sponsor code: 03602
Other descriptive name: Tracleer
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 62,5-250
|
|
Primary Outcome(s)
|
Primary end point(s): change in aerobic capacity.
Sample size calculation is based on the primary endpoint change in aerobic capacity (percentage of predicted VO2max). Giardini et al (2008) found a mean improvement in peak V’O2 of 1.9 ml/kg/min (change 9.% ± 5.2%) after treatment with sildenafil in 18 patients with a Fontan circulation (78% total cavo-pulmonary connection).6 Based on a standard deviation of 1.89 we calculated that 32 patients are required to obtain 80% power to detect a difference in mean percentage of peak VO2 2.0 ml/kg/min between the two groups after 12 weeks with a 2 sided a of 0.05. To accommodate for a 10% drop out, the inclusion of at least 40 patients is advised. According to the CONCOR database, the capacity of our study centres meets this criterion
|
Secondary Objective: Change in:
a. changes in six-minute-walk-distance
b. change in quality of life score
c. change in prevalence of arrhythmias
d. changes in congestive heart failure (hospital admission, use of medication for congestive heart failure e. changes in prevalence of protein losing enteropathy f. changes in serum of neurohormones level (NT-pro BNP, endothelin-1)
g. changes in cardiac output
h changes in arterial oxygen saturation
i. changes in number of deaths
|
|
Main Objective: To study whether bosentan (endothelin receptor inhibitor) improves aerobic capacity (VO2max) and exercise performance in adult patients with a Fontan operation.
|
|
Source(s) of Monetary Support
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|