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Table 1 In-/exclusion criteria

From: The effect of Bosentan on exercise capacity in Fontan patients; rationale and design for the TEMPO study

Inclusion criteria
Fontan/TCPC operated
Expected clinical stability > 3 months, evaluated by investigator from clinical record
Exclusion criteria
Age < 12 years
Severe heart failure (NYHA-class IV)
Oxygen saturation < 85% at rest
Pre-existing liver condition (transaminases 2x > upper reference limit)
Renal failure (creatinin > 150 mmol/l)
Restrictive Fontan circuit
History of work induced severe arrhythmia
Systolic blood pressure below 80% of reference (< 88 mmHg)
Use of any of following drugs: Fluconazole, Ketoconazole, CyclosporineA, Lopinavir, Ritonavir, Rifampicin, Carbamazepine and Phenytoin
Severe extra-cardiac condition e.g. neurological impairment
For women: Positive HCG or no use of contraception*
History of low compliance
  1. TCPC: Total Cavo-Pulmonary Connection, NYHA: New York Heart Association, HCG: Human Chorionic Gonadotropin, *: contraception includes celibacy.