Cross-sectional stage | Longitudinal change | ||||
Screening | Baseline | Year 1 | Year 2 | Year 3 or earlier# | |
Informed consent¶ | Yes | ||||
Check of eligibility criteria | Yes | ||||
Demographics | Yes | ||||
Medical history | Yes | ||||
Pulmonary function tests+ | Yes | Yes | Yes | Yes | |
Concomitant medication | Yes | Yes | Yes | Yes | |
SSc characteristics | Yes | Yes | Yes | Yes | |
Serum analysis by central lab | Yes | Yes | |||
Serum storage by central lab | Yes | Yes | Yes | Yes | |
Physical examination | Yes | Yes | Yes | Yes | |
Echocardiography | Yes | Yes | Yes | Yes | |
ECG | Yes | Yes | Yes | Yes | |
RHC§ | Yes | Yes | |||
6MWT, Borg dyspnoea index | Yes | Yes | Yes | Yes | |
NYHA functional classƒ | Yes | Yes |
SSc: systemic sclerosis; RHC: right heart catheterisation; 6MWT: 6-min walk test; NYHA: New York Heart Association. #: earlier in case of suspected pulmonary hypertension before year 3 requiring RHC, or for patients predictably unable to stay in the study; ¶: obtained before any invasive procedure; +: diffusing capacity of the lung for carbon monoxide/alveolar volume, forced vital capacity, forced expiratory volume in 1 s, total lung capacity and residual volume; §: RHC performed as last test in order to exclude bias regarding any other test but not later than 2 months after the other tests; pregnancy is contraindicated; ƒ: for patients diagnosed with pulmonary arterial hypertension or pulmonary hypertension.