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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01827059 |
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Date of registration:
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05/04/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasE
BICYCLE |
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Scientific title:
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A Randomized Placebo Controlled Trial to Analyze Changes in Pulmonary Arterial Pressures at Peak Exercise in Congenital Heart Disease Patients With Exercise-induced Pulmonary Arterial Hypertension Before and After Treatment With Bosentan, Compared to Placebo |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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12 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01827059 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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B.J. Bouma, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Academic Medical Centre |
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Name:
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B.J.M. Mulder, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Academic Medical Centre |
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Name:
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A.C.J.M. van Riel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Academic Medical Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult (>18 years) and mentally competent
- Open or closed septal defect (ASD I/II, VSD, AVSD)
- Open or closed systemic-to-pulmonary shunt (PDA, PAPVC)
- Negative pregnancy test
- Presence of X-PAH
- One of the following criteria, at peak exercise.
- mPAP > 34 mmHg with CO = 10 l/min
- mPAP > 40 mmHg with CO = 15 l/min
- mPAP > 45 mmHg with CO = 20 l/min
- mPAP > 50 mmHg with CO = 30 l/min
- a PVR (slope pressure/flow plot) of > 3 mmHg/l/min
Exclusion Criteria:
- Incapable of giving informed consent
- Pregnancy or lactation (a pregnancy test is offered to every female patient within
fertile age)
- Women of child-bearing age who are sexually active without practising reliable methods
of contraception. The use of oral contraceptives only, is not considered reliable.
Reliable methods include concomitant use of oral contraceptives and condoms ("Double
Dutch"), and those methods with a less than 1% chance of pregnancy during typical
use20, including intrauterine contraceptives (Copper T, Mirena), Implanon, and
sterilization.
- Substance abuse (alcohol, medicines, drugs)
- Subjects who are not able to perform cardiopulmonary exercise testing
- Any cardiac operation < 6 months before inclusion
- PAH of any aetiology other than the one specified in the inclusion criteria
- Left ventricular ejection fraction < 30%
- Significant impairment of renal function (GFR < 30 ml/min/1.73m2)
- Moderate to severe liver disease: Child Pugh class B or C
- Raised plasma transaminases level > three times upper normal limit
- Arterial hypotension (systolic blood pressure < 85mmHg)
- Anaemia (Hb < 10g/L, or <6.21 mmol/L)
- Significant valvular disease, other than tricuspid or pulmonary regurgitation
- Chronic lung disease or total lung capacity < 80% predicted value
- History of significant pulmonary embolism
- Other relevant diseases (HIV infection, Hep B/C infection)
- Subjects with known intolerance to bosentan or their constituents
- Prohibited medication: any medication listed below which has not been discontinued at
least 30 days prior to inclusion
- Unspecified or other significant medication (glibenclamide or immunosuppression)
- PAH therapy (endothelin receptor antagonists, PDE-5 inhibitors, prostanoids)
- Medication which is not compatible with bosentan or interferes with its
metabolism (inhibitors or inducers of CYP2C9, CYP3A4) or medication which may
interfere with bosentan treatment according to the investigator
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Congenital Heart Disease
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Bosentan
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Drug: Placebo
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Primary Outcome(s)
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Change in mean pulmonary arterial pressure (mPAP) at peak exercise
[Time Frame: 26 weeks]
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Secondary Outcome(s)
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Demographics
[Time Frame: 26 weeks]
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Laboratory parameters
[Time Frame: 26 weeks]
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Cardiopulmonary exercise capacity
[Time Frame: 26 weeks]
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Right ventricular function
[Time Frame: 26 weeks]
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NYHA functional class
[Time Frame: 26 weeks]
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Pulmonary hemodynamics
[Time Frame: 26 weeks]
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Quality of life
[Time Frame: 26 weeks]
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Secondary ID(s)
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NL 42568.018.12
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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