Chronic Thromboembolic Pulmonary Hypertension Clinical Trial
Official title:
Mechanisms of Exertional Dyspnea in Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Verified date | April 2023 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 of patients, however, develop complications (high blood pressure in the lung circulation, i.e. pulmonary hypertension). Persisting breathlessness during activity is a common symptom in many of these patients and leads to a reduced ability to engage in daily physical activity. The reason for this activity-related breathlessness remains uncertain and is the main question of the proposed study. Using new sophisticated technology, the investigators will determine the root causes of perceived breathing difficulty. The investigators will test the idea that breathlessness is fundamentally the result of increased drive to breathe from control centers in the brain. The investigators will measure drive to breathe by measuring the electrical activity descending from the brain to the main muscle of breathing - the diaphragm. The investigators will discover if the increased drive to breathe is due to accumulation of carbon dioxide in the blood as a result of poor blood perfusion of areas of the lung due to the effects of blockage by clots. The investigators also will investigate whether weakness and fatigue of the muscles of breathing, as a result of the high breathing demands that are present in patients with blood clots in the lungs, contribute to breathlessness. With this information it is hopeful that better treatment options will be developed to relieve this distressing symptom.
Status | Completed |
Enrollment | 28 |
Est. completion date | January 1, 2023 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: 1. 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 2. male or female =40 years of age 3. non-smoker 4. 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 5. ability to perform all study procedures and provide/sign informed consent. Exclusion Criteria: 1. women of childbearing age who are pregnant or trying to become pregnant 2. active cardiopulmonary disease or other comorbidities that could contribute to dyspnea and exercise limitation 3. important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s) 4. use of daytime oxygen or exercise-induced O2 desaturation to < 80% on room air 5. body mass index (BMI) <18.5 or =35.0 kg/m2 6. 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 7. systemic connective tissue disease |
Country | Name | City | State |
---|---|---|---|
Canada | Respiratory Investigation Unit, Kingston General Hospital | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Dr. Denis O'Donnell | Queen's University |
Canada,
Faisal A, Alghamdi BJ, Ciavaglia CE, Elbehairy AF, Webb KA, Ora J, Neder JA, O'Donnell DE. Common Mechanisms of Dyspnea in Chronic Interstitial and Obstructive Lung Disorders. Am J Respir Crit Care Med. 2016 Feb 1;193(3):299-309. doi: 10.1164/rccm.201504-0841OC. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diaphragm electromyography (EMGdi) at a standardized time during cycle exercise test | EMGdi will be used as an index of inspiratory neural drive. Assessments will be compared at a standardized time (at rest, during isotime and end-exercise) during incremental cycle ergometer exercise test. | Conducted at visit 2, 2-7 days after screening visit | |
Primary | Dyspnea intensity measured by the 10-point Borg Scale at a standardized time during cycle exercise test | The 10-point Borg scale ranges from 0 "nothing at all" to 10 "maximal/extremely strong" and will be used to rate the intensity of dyspnea during exercise: a decrease in this rating signifies an improvement. Dyspnea intensity will be assessed at a standardized time (every minute) during incremental cycle ergometer exercise test. | Conducted at visit 2, 2-7 days after screening visit | |
Secondary | Inspiratory Capacity at a standardized time during cycle exercise test | Exercise measurements of inspiratory capacity will be compared at a standardized time (at rest, during isotime and end-exercise) during incremental cycle ergometer exercise test. | Conducted at visit 2, 2-7 days after screening visit | |
Secondary | Ventilation at a standardized time during cycle exercise test | Exercise measurements of ventilation will be compared at a standardized time (at rest, during isotime and end-exercise) during incremental cycle ergometer exercise test. | Conducted at visit 2, 2-7 days after screening visit | |
Secondary | Breathing frequency at a standardized time during cycle exercise test. | Exercise measurements of breathing frequency (respiratory rate) will be compared at a standardized time (at rest, during isotime and end-exercise) during incremental cycle ergometer exercise test. | Conducted at visit 2, 2-7 days after screening visit | |
Secondary | Carbon dioxide output (VCO2) at a standardized time during cycle exercise test. | Exercise measurements of Carbon Dioxide output (VCO2) will be compared at a standardized time (at rest, during isotime and end-exercise) during incremental cycle ergometer exercise test. | Conducted at visit 2, 2-7 days after screening visit | |
Secondary | Maximal oxygen uptake (VO2) at a standardized time during cycle exercise test. | Exercise measurements of Maximal oxygen uptake (VO2) will be compared at a standardized time (at rest, during isotime and end-exercise) during incremental cycle ergometer exercise test. | Conducted at visit 2, 2-7 days after screening visit |
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