Cardiopulmonary Exercise Testing to Evaluate Pulmonary AVMs With and Without Airflow Obstruction
ExercisePAVM2
Hypoxemia, Dyspnea, and Exercise Tolerance in Patients With Pulmonary Arteriovenous Malformations , With and Without Airflow Obstruction
2 other identifiers
interventional
60
0 countries
N/A
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, and whether this is affected by the presence of concurrent airflow obstruction, such as due to asthma.
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 May 2015
Typical duration for not_applicable
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
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 28, 2015
CompletedFirst Posted
Study publicly available on registry
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedJune 1, 2015
April 1, 2015
3 years
May 28, 2015
May 29, 2015
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 with and without airflow obstruction."
Same day (within 1 hour), at end of exercise study
Secondary Outcomes (2)
Breathing reserve
Same day (within 1 hour), at end of exercise study
Ventilatory efficiency
Same day (within 1 hour), at end of exercise study
Study Arms (2)
Patients with pulmonary AVMs and no airflow obstruction
EXPERIMENTAL30 patients with pulmonary AVMs and no airflow obstruction will undergo cardiopulmonary exercise testing
Patients with pulmonary AVMs and airflow obstruction
EXPERIMENTAL30 patients with pulmonary AVMs and airflow obstruction will undergo cardiopulmonary exercise testing
Interventions
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", they will fill in a short questionnaire describing how they feel. 20-30mls of blood will be taken for analysis.
Eligibility Criteria
You may qualify if:
- Ability to provide informed consent
- Pulmonary AVMs no airflow obstruction: Pulmonary AVMs confirmed by CT scan and no evidence or history of airflow obstruction on clinical grounds, or by spirometric evaluations.
- Pulmonary AVMs with airflow obstruction: Pulmonary AVMs confirmed by CT scan and evidence or history of airflow obstruction on clinical grounds, and/or by spirometric evaluations (such as FEV1/VC ratio \<80%).
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
Related Publications (1)
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: 24676541BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claire L Shovlin, PhD FRCP
Hammersmith Hospital, Du Cane Rd, London, United Kingdom, W12 0NN
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2015
First Posted
June 1, 2015
Study Start
May 1, 2015
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
June 1, 2015
Record last verified: 2015-04