Status:
COMPLETED
Inhaled Nitric Oxide (iNO) in Post-Pulmonary Embolism (Post-PE)
Lead Sponsor:
Dr. Denis O'Donnell
Conditions:
Dyspnea
Pulmonary Embolism
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
Following acute pulmonary embolism (PE), up to a third of patients develop post-PE syndrome described as having persistent breathlessness (dyspnea), impaired exercise capacity, and a reduced quality o...
Detailed Description
Background: Following acute pulmonary embolism (PE), up to a third of patients develop post-PE syndrome characterized by persistent breathlessness (dyspnea), impaired exercise capacity, and reduced q...
Eligibility Criteria
Inclusion
- 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;
- 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;
- male or female non-pregnant adults \>20 years of age;
- ability to perform all study procedures
- ability to provide informed consent
Exclusion
- women of childbearing potential who are pregnant or trying to become pregnant;
- echocardiographic evidence of pulmonary hypertension
- prior history of unstable pulmonary thromboembolism or systemic connective tissue vasculopathy,
- active cardiopulmonary disease or other comorbidities that could contribute to dyspnea and exercise limitation;
- history/clinical evidence of asthma, atopy and/or nasal polyps;
- history of hypercapnic respiratory failure or a clinical diagnosis of sleep disordered breathing;
- important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s);
- body mass index (BMI) \<18.5 or ≥35.0 kg/m2;
- use of daytime oxygen or exercise-induced O2 desaturation (\<80% on room air).
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04920695
Start Date
May 14 2021
End Date
May 30 2023
Last Update
April 3 2024
Active Locations (1)
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1
Respiratory Investigation Unit, Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7