Cardiopulmonary Exercise Testing to Evaluate Pulmonary AVMs
Hypoxemia, Dyspnea, and Exercise Tolerance in Patients With Pulmonary Arteriovenous Malformations
2 other identifiers
interventional
39
1 country
1
Brief Summary
Pulmonary arteriovenous malformations (PAVMs) are a rare vascular condition affecting the lungs. PAVMs lead to low blood oxygen levels, yet are very well tolerated by patients. This study will examine the exercise capacity of PAVM patients using formal cardiopulmonary exercise tests performed on a stationary bicycle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2015
CompletedSeptember 28, 2023
September 1, 2023
3.9 years
October 16, 2012
September 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total body oxygen consumption in mls/min/kg, at peak exercise (VO2 max).
Of the many measurements and derived indices that can be measured during cardiopulmonary exercise testing, the peak consumption of oxygen (VO2 max) is perhaps the best indicator of integrated cardiorespiratory capacity. The principle research question will therefore test the null hypothesis that "The VO2 max does not differ between PAVM patients and age matched healthy controls."
Same day (Day 1), at end of exercise study
Secondary Outcomes (2)
Breathing reserve (%)
Same day (Day 1) at end of exercise test
Ventilatory efficiency, derived from the VE / CO2 slope (L/min/L/min)
Same day (Day 1), at end of exercise study
Study Arms (3)
Healthy control
EXPERIMENTALA group of up to 30 healthy controls will be recruited to have a cardiopulmonary exercise test and a blood test.
Pulmonary AVM
EXPERIMENTALA group of up to 30 pulmonary AVM patients will be recruited to have a cardiopulmonary exercise test, and a blood test.
HHT but no pulmonary AVM
EXPERIMENTALMost patients with pulmonary AVMs have underlying hereditary hemorrhagic telangiectasia (HHT). If there is a difference between pulmonary AVM and control groups that does not correct following embolization of pulmonary AVMs, a group of up to 30 people with HHT but no evidence of pulmonary AVMs will be selected to have a cardiopulmonary exercise test and a blood test.
Interventions
On Day 1, subjects will have the test in the Exercise Suite of Hammersmith Hospital, London, UK. They will have painless skin probes placed on their fingers, chest, and legs to monitor heart rate, ECG, blood oxygen levels, and oxygen delivery during the test. Subjects will also be shown how to breathe through a mouthpiece with a nose clip on, and how to indicate on a sliding device whether they feel breathless. They will then start cycling against a very low resistance at a steady speed. As long as they feel comfortable, there will be a gradual increase in work load until they feel they cannot keep going at the same speed. They can also stop sooner for any reason. Afterwards, while they are "cooling down" (within the hour on Day 1), they will fill in a short questionnaire describing how they feel.
On same day (Day 1), the subject will have 20-30mls of blood (that is, 4-6 teaspoonful) taken for analysis.
Eligibility Criteria
You may qualify if:
- Ability to provide informed consent
- Healthy volunteers: no concurrent health reason to avoid exercise
- Pulmonary AVMs: pulmonary AVMs confirmed by CT scan
- Hereditary hemorrhagic telangiectasia without pulmonary AVMs: HHT according to current international consensus criteria, with no evidence of PAVMs on dedicated thoracic CT scan.
You may not qualify if:
- Inability to provide informed consent.
- Any known cardiovascular abnormality including a history of syncope (faintness, dizziness, lightheadedness or loss of consciousness due to an abnormality of the cardiovascular system).
- Current respiratory tract infection (eg a cold).
- Pregnancy.
- Claustrophobia or needle phobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hammersmith Hospital, Du Cane Rd
London, W12 0NN, United Kingdom
Related Publications (2)
Howard LSGE, Santhirapala V, Murphy K, Mukherjee B, Busbridge M, Tighe HC, Jackson JE, Hughes JMB, Shovlin CL. Cardiopulmonary exercise testing demonstrates maintenance of exercise capacity in patients with hypoxemia and pulmonary arteriovenous malformations. Chest. 2014 Sep;146(3):709-718. doi: 10.1378/chest.13-2988.
PMID: 24676541RESULTGawecki F, Strangeways T, Amin A, Perks J, McKernan H, Thurainatnam S, Rizvi A, Jackson JE, Santhirapala V, Myers J, Brown J, Howard LSGE, Tighe HC, Shovlin CL. Exercise capacity reflects airflow limitation rather than hypoxaemia in patients with pulmonary arteriovenous malformations. QJM. 2019 May 1;112(5):335-342. doi: 10.1093/qjmed/hcz023.
PMID: 30657990RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claire L Shovlin
Imperial College London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2012
First Posted
May 6, 2015
Study Start
April 1, 2011
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
September 28, 2023
Record last verified: 2023-09