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Abnormal diffusion capacity of the lung on exercise in patients with high blood pressure in the blood channels of the lung also known as pulmonary arterial hypertension

A pilot study: impaired pulmonary diffusion capacity on exercise in patients with pulmonary arterial hypertension

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN65855577
Enrollment
30
Registered
2024-02-26
Start date
2024-03-15
Completion date
Unknown
Last updated
2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary hypertension Circulatory System

Interventions

The study will involve recruiting PAH patients on PH-specific targeted therapies and ten age-matched healthy controls who will complete baseline pulmonary diffusion capacity measured at rest and immed

Sponsors

Mater Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactCiara McCormack
ciaramccormack@eril.ie

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026