Status:
COMPLETED
Dyspnea in Chronic Thromboembolic Pulmonary Hypertension
Lead Sponsor:
Dr. Denis O'Donnell
Collaborating Sponsors:
Queen's University
Conditions:
Chronic Thromboembolic Pulmonary Hypertension
Eligibility:
All Genders
40+ years
Brief Summary
Pulmonary embolism, or clots blocking the blood vessels of the lungs, is a common clinical condition requiring treatment with blood thinners. In most patients, recovery is complete. A small proportion...
Detailed Description
Rationale: In patients with pulmonary embolism, most assessments of the burden of blood clots and possible related complications, currently rely on chest imaging and heart ultrasound. While these test...
Eligibility Criteria
Inclusion
- clinically stable 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
- male or female ≥40 years of age
- non-smoker
- moderate-to-severe chronic activity-related dyspnea as defined by a modified Medical Research Council (MRC) dyspnea scale ≥2, or Baseline Dyspnea Index focal score ≤ 6
- ability to perform all study procedures and provide/sign informed consent.
Exclusion
- women of childbearing age who are pregnant or trying to become pregnant
- active cardiopulmonary disease or other comorbidities that could contribute to dyspnea and exercise limitation
- important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s)
- use of daytime oxygen or exercise-induced O2 desaturation to \< 80% on room air
- body mass index (BMI) \<18.5 or ≥35.0 kg/m2
- other causes of significant pulmonary hypertension: pulmonary arterial hypertension, left heart disease, chronic pulmonary disease including, obstructive sleep apnea or pulmonary hypertension of unclear or multifactorial mechanism
- systemic connective tissue disease
Key Trial Info
Start Date :
November 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03786367
Start Date
November 1 2018
End Date
January 1 2023
Last Update
April 13 2023
Active Locations (1)
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1
Respiratory Investigation Unit, Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7