Pulmonary hypertension Circulatory System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Group 1 PAH: 1. Patients with diagnosed idiopathic pulmonary artery hypertension (IPAH)/drug-induced pulmonary artery hypertension (DPAH)/heritable pulmonary arterial hypertension (HPAH)/connective tissue disease (CTD) PAH who are stable for the past three months on PH-specific targeted therapy. 2. Normal spirometry 3. No evidence of interstitial lung diseases (ILD)/emphysema on CT scan 4. Never smokers or ex-smokers with less than equal to 10 pack years h/o smoking 5. Age 18-65 years Age-matched controls: 1. No h/o cardiovascular disease 2. BMI <25 kg/m² 3 Never smoker 4. Normal spirometry 5. Do not currently meet the recommended physical activity government guidelines of at least 150 minutes of moderate-intensity aerobic activity per week 6. Age 18-65 years
Exclusion criteria
Exclusion criteria: 1. Unable to provide written consent 2. Unable to perform the incremental shuttle walk test 3. Pregnant and breastfeeding mothers 4. Healthy volunteers with abnormal pulmonary function test (PFT) data 5. Control group or PAH patients who cannot obtain two reproducible baseline DLCO measurements within three attempts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in DLCO immediately (within 1-2 min) following exercise (DLCO at maximum exercise minus DLCO at rest) measured by modified Kroghs single breath method | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cardiac effort: total number of heartbeats divided by the total distance travelled in the incremental shuttle walk test (ISWT) 2. Heart rate reserve at the end of exercise (maximum heart rate minus resting heart rate) 3. % of maximum predicted heart rate (maximum heart rate divided by 220-Age in years multiplied by 100) 4. % of maximum predicted walk distance achieved at the end of exercise (ISWTpred = 1449.701 - (11.735 × age) + (241.897 × gender) - (5.686 × BMI), where male gender = 1 and female gender = 0) Total walk distance achieved (m)/predicted walk distance (m)x 100 5. Heart rate recovery in the first minute immediately after the end of exercise (maximum heart rate - heart rate after 1 min of having stopped exercise) 6. Change of oxygen saturation immediately before the end of exercise (oxygen saturation at rest - minimum oxygen saturation achieved just before the end of exercise) 7. Calculated peak oxygen consumption at the end of exercise (VO2 peak (predicted) = 19.793 + (0.02 x distance walked)-(0.236 x age)) 8. Change in DLCO/heart rate slope between rest and exercise (DLCO at rest / resting heart rate minus DLCO at peak exercise / maximum heart rate achieved) 9. Breathlessness measured using modified Borg score immediately at the end of exercise 10. Body weight (kg) x distance (m) product measured at the end of exercise 11. Quality of life measured using the Emphasis 10 scale at the start of the trial Devices used to collect measures: PFT System: Vyntus ONE PFT system ISWT: Vyntus walk tablet with Spo2 Spo2/HR: Nonin Pulse Oximeter | — |
Countries
Ireland