Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT01468792
Eligibility Criteria:
Inclusion Criteria:
* Informed consent
* Patients with systemic sclerosis, mixed connective tissue disease, (systemic lupus erythematodes) SLE or overlap syndrome
* Existing exercise Doppler echocardiography or/and right heart catheterization 3-5 years before inclusion
Exclusion Criteria:
* \- Severe lung or bronchial disease (FEV1 \<60%)
* Systolic LV dysfunction (LVEF \<50%) or diastolic dysfunction \> grade I
* Valvular defect \> grade I (except for tricuspid- or pulmonary insufficiency)
* Uncontrolled systemic arterial hypertension (at rest \>150 mmHg systolic or 95 mmHg diastolic)
* Uncontrolled ventricular arrhythmias
* Uncontrolled bradycardia or tachycardia supraventricular arrhythmias
* Myocardial infarction within the last 12 months
* Pulmonary embolism within the last 12 months
* Relevant changes in hemodynamic therapy or major surgery within the last 12 weeks
* Musculoskeletal or peripheral vessel disorders which complicates an ergometry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01468792
Study Brief:
Protocol Section:
NCT01468792