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

Table 4 Visits

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

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.

ISSN: 1471-2261