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The role of Bosentan in fontan patients: improvement of aerobic capacity.


- candidate number4588
- NTR NumberNTR1557
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-nov-2008
- Secondary IDs03602 
- Public TitleThe role of Bosentan in fontan patients: improvement of aerobic capacity.
- Scientific TitleThe role of Bosentan in fontan patients: improvement of aerobic capacity.
- ACRONYMN/A
- hypothesisIn adult Fontan patients, treatment with bosentan, an endothelin receptor antaganost (ERA) lowers the pulmonary vascular resistance, which may result in improvement of the cardiopulmonary circulation and functional capacity.
- Healt Condition(s) or Problem(s) studiedQuality of life, Bosentan, Arrhythmias, Enteropathy, Aerobic capacity
- Inclusion criteria1. All adult Fontan patients are potentially eligible for this study.
- Exclusion criteria- Patients are not eligible for this study if the following inclusion criteria apply:
1. Systemic arterial pressure < 85 mmHg
2. Incapable of giving informed consent
3. Hypersensitivity to bosentan or any of its help substances
4. Current treatment with bosentan or treatment for pulmonary arterial hypertension
5. Moderate to severe liver disease: Child-Pugh class B or C
6. Raised plasma transaminases level > three times limiting value
7. Simultaneous use of cyclosporine A
8. Desire to have children within the study period or women who do not use reliable contraceptive methods
9. Pregnant or nursing women
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2008
- planned closingdate1-jun-2010
- Target number of participants40
- InterventionsOne group receives a 125 mg tablet of Bosentan twice daily for 6 months. The other group does not receive study medication for the first 3 months, followed by treatment with study medication for 6 months.
- Primary outcomeThe primary objective of this study is to determine changes in aerobic capacity (peak VO2) in adult patients with a Fontan circulation before and after treatment with the bosentan and compared to non-treated patients.
- Secondary outcomeTo determine the effect of the following parameters.
- changes in six-minute-walk-distance
- changes in quality of life score
- changes in prevalence of arrhythmias
- changes in congestive heart failure
(hospital admission, use of medication for congestive heartfailure)
- changes in prevalence of protein losing enteropathy
- changes in serum neurohormone level (NT-pro BNP, endothelin-1, albumin)
- changes in cardiac output
- changes in arterial oxygen saturation
- changes in number of deaths
- Timepointsbaseline, 3 months, and after 6 months of bosentan treatment.
During bosentan treatment regularly laboratory testing will be performed
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES B.J.M. Mulder
- CONTACT for SCIENTIFIC QUERIESMD, PhD B.J. Bouma
- Sponsor/Initiator Academic Medical Center (AMC), Department of Cardiology
- Funding
(Source(s) of Monetary or Material Support)
Actelion Pharmaceuticals
- PublicationsN/A
- Brief summaryThe Fontan procedure is a palliative surgical procedure used in patients with complex congenital heart defects. It involves diverting the venous blood from the right atrium to the pulmonary arteries without passing through the right ventricle. A low pulmonary vascular resistance (PVR) is crucial to preserve the Fontan circulation. Plasma endothelin-1 level, a vasoconstrictor which increases pulmonary vascular resistance, is elevated in patients with Fontan circulation. Treatment with bosentan, an endothelin receptor antagonist (ERA) lowers the pulmonary vascular resistance, which may result in improvement of the cardiopulmonary circulation.
- Main changes (audit trail)
- RECORD24-nov-2008 - 2-dec-2008


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