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 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
NCT ID:
NCT04920695
Eligibility Criteria:
Inclusion Criteria:
1. clinically stable CTED or post-PE syndrome patients, as defined by stable hemodynamic status, optimized medical treatment, no changes in medication dosage or frequency of administration with no hospital admissions in the preceding 6 weeks;
2. a diagnosis of persistent, moderate to severe exertional dyspnea ≥ 6 months following PE as confirmed by study physician at time of enrollment by a modified Medical Research Council (mMRC) dyspnea scale =2, or Baseline Dyspnea Index (BDI) focal score \<=6;
3. male or female non-pregnant adults \>20 years of age;
4. ability to perform all study procedures
5. ability to provide informed consent
Exclusion Criteria:
1. women of childbearing potential who are pregnant or trying to become pregnant;
2. echocardiographic evidence of pulmonary hypertension
3. prior history of unstable pulmonary thromboembolism or systemic connective tissue vasculopathy,
4. active cardiopulmonary disease or other comorbidities that could contribute to dyspnea and exercise limitation;
5. history/clinical evidence of asthma, atopy and/or nasal polyps;
6. history of hypercapnic respiratory failure or a clinical diagnosis of sleep disordered breathing;
7. important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s);
8. body mass index (BMI) \<18.5 or ≥35.0 kg/m2;
9. use of daytime oxygen or exercise-induced O2 desaturation (\<80% on room air).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04920695
Study Brief:
Protocol Section:
NCT04920695