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Table 4 Visits

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

Visit/week Baseline Increase medication Safety visit Safety visit Endpoint
Place Cph Tertiary Local Local Cph
Time window Day 0 Day 10-18 Day 35-49 Day 63-77 Day 91-105
Bosentan dose after visit 62.5 mg x 2 125 mg x 2 None
In-/exclusion criteria, informed consent X     
Exercise test, SF36 q.o.l., α1-AT X     X
Blood pressure, heart rate, SAT X X X X X
Blood pressure/hypotension control X X    
Compliance control and adverse effects   X X X X
CT-proET-1, IgA, IgG, Pro-BNP, albumin, protein, LDH X     X
ALAT, ASAT, bilirubin, creatinine, PCV, Hb, thrombocytes, (women) HCG X X X X X
  1. Cph: Copenhagen University Hospital, Rigshospitalet, Tertiary: Any of the four participating tertiary centers, Local: Local hospital including tertiary center or general practitioners office, SF36 q.o.l.: SF36 quality of life questionnaire, α1-AT: fecal α1-antitrypsin, SAT: transcutaneous oxygen saturation, CT-proET-1: C-terminal proendothelin-1, IgA-G: Immunoglobulin A-G, Pro-BNP: Pro-Brain Natriuretic Peptide, LDH: Lactate dehydrogenase, ALAT/ASAT: Alanine-/aspartate aminotransferase, PCV: Packed cell volume/hematocrit, Hb: Hemoglobin, HCG: Human chorionic gonadotropin.