Analysis of the diagnostic value of cardiopulmanary exercise testing for the detection and prediction of pulmonary complications in patients with systemic sclerosis

Analysis of the diagnostic value of cardiopulmanary exercise testing for the detection and prediction of pulmonary complications in patients with systemic sclerosis - SScPAHCPX

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00009558

Enrollment

Registered

2015-11-09

Start date

2015-11-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M34.0 I27.28

Interventions

Group 1: Patients with SSc +/- PAH +/- pulmonary fibrosis: Cardiopulmonary exercise testing on a treadmill (consists of a combination of stress electrocardiography (ECG) and pulmonary function test, t

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - patients with systemic sclerosis - informed consent - sufficient health status of the patient

Exclusion criteria

Exclusion criteria: - missing informed consent - high level of dyspnea/ respiratory insufficiency (NYHA IV) - angina pectoris at rest (CCS IV)

Design outcomes

Primary

Measure	Time frame
This study is a pilot experiment regarding the diagnostic value of cardiopulmonary exercise testing assessing PAH in systemic sclerosis Two parameters VE/VCO2AT and PETCO2AT are being investigated simultaneously regarding their discriminatory power between patients with systemic sclerosis with or without PAH or pulmonary fibrosis. It is known that the quotient VE/VCO2AT is 29.8±2.9 in patients with systemic sclerosis and normal functional capacity, 30.2±2.4 in patients with left-ventricular dysfunction and 30.2±2.4 in patients with pulmonary vasculopathy (Dumitrescu et al, Developing pulmonary vasculopathy in systemic sclerosis, detected with non-invasive cardiopulmonary exercise testing. PLoS One. 2010 Dec 13;5(12):e14293); in patients with PAH values of 47.0±1.2 and 53±1.1 respectively were obtained (Schwaiblmair et al. Ventilatory efficiency testing as prognostic value in patients with pulmonary hypertension. BMC Pulmonary Medicine 2012, 12:23 und Hansen et al. Reproducibility of Cardiopulmonary Exercise Measurements in Patients With Pulmonary Arterial Hypertension. Chest. 2004 Sep;126(3):816-24.). PETCO2 is 37.9±4.5 in patients with systemic sclerosis and normal functional capacity, 37.4±4.0 in patients with left-ventricular dysfunction, 31.0±2.5 in patients with pulmonary vasculopathy and 27±0.6 in patients with PAH. Assuming a difference of VE/VCO2AT between two groups =5 and PETCO2AT =5mmHg respectively with a mean standard deviation of 4, n=20 patients per group are needed to test the discriminatory power of both parameters between all 4 subgroups with 6 paired t-tests with an adjusted significance level of a*=0.004 and a power of 80%.	—

Measure

Time frame

This study is a pilot experiment regarding the diagnostic value of cardiopulmonary exercise testing assessing PAH in systemic sclerosis Two parameters VE/VCO2AT and PETCO2AT are being investigated simultaneously regarding their discriminatory power between patients with systemic sclerosis with or without PAH or pulmonary fibrosis. It is known that the quotient VE/VCO2AT is 29.8±2.9 in patients with systemic sclerosis and normal functional capacity, 30.2±2.4 in patients with left-ventricular dysfunction and 30.2±2.4 in patients with pulmonary vasculopathy (Dumitrescu et al, Developing pulmonary vasculopathy in systemic sclerosis, detected with non-invasive cardiopulmonary exercise testing. PLoS One. 2010 Dec 13;5(12):e14293); in patients with PAH values of 47.0±1.2 and 53±1.1 respectively were obtained (Schwaiblmair et al. Ventilatory efficiency testing as prognostic value in patients with pulmonary hypertension. BMC Pulmonary Medicine 2012, 12:23 und Hansen et al. Reproducibility of Cardiopulmonary Exercise Measurements in Patients With Pulmonary Arterial Hypertension. Chest. 2004 Sep;126(3):816-24.). PETCO2 is 37.9±4.5 in patients with systemic sclerosis and normal functional capacity, 37.4±4.0 in patients with left-ventricular dysfunction, 31.0±2.5 in patients with pulmonary vasculopathy and 27±0.6 in patients with PAH. Assuming a difference of VE/VCO2AT between two groups =5 and PETCO2AT =5mmHg respectively with a mean standard deviation of 4, n=20 patients per group are needed to test the discriminatory power of both parameters between all 4 subgroups with 6 paired t-tests with an adjusted significance level of a*=0.004 and a power of 80%.

—

Countries

Germany

Contacts

Public ContactElise Siegert

Charité - Universitätsmedizin Berlin

elise.siegert@charite.de+49 30 450 613 263

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026