Cardiopulmonary Exercise Testing to Evaluate Pulmonary AVMs With and Without Airflow Obstruction (ExercisePAVM2)
Primary Purpose
Pulmonary Arteriovenous Malformations, Hereditary Hemorrhagic Telangiectasia, Asthma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardiopulmonary exercise test
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Arteriovenous Malformations focused on measuring workload, oxygen level, oxygen consumption, breathing reserve, ventilatory efficiency
Eligibility Criteria
Inclusion Criteria:
- 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%).
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients with pulmonary AVMs and no airflow obstruction
Patients with pulmonary AVMs and airflow obstruction
Arm Description
30 patients with pulmonary AVMs and no airflow obstruction will undergo cardiopulmonary exercise testing
30 patients with pulmonary AVMs and airflow obstruction will undergo cardiopulmonary exercise testing
Outcomes
Primary Outcome Measures
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."
Secondary Outcome Measures
Breathing reserve
We will also test in univariate and multiple regression analyses whether breathing reserve differs between PAVM patients with and without airflow obstruction.
Ventilatory efficiency
We will also test in univariate and multiple regression analyses whether ventilatory efficiency differs between PAVM patients with and without airflow obstruction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02458703
Brief Title
Cardiopulmonary Exercise Testing to Evaluate Pulmonary AVMs With and Without Airflow Obstruction
Acronym
ExercisePAVM2
Official Title
Hypoxemia, Dyspnea, and Exercise Tolerance in Patients With Pulmonary Arteriovenous Malformations , With and Without Airflow Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
It is well known that the lung is the site at which oxygen enters the blood stream, diffusing from the alveolar air sacs into the pulmonary capillaries. This newly oxygenated blood is carried to the heart in the pulmonary veins, then passes into the systemic circulation to provide oxygen to the tissues.
Patients with pulmonary arteriovenous malformations (PAVMs) have abnormal vascular connections between pulmonary arteries and pulmonary veins in the lung. Blood flowing through PAVMs therefore bypasses the oxygenation sites in the pulmonary capillaries. Low blood oxygen levels (hypoxemia) is frequent in PAVM patients but breathlessness (dyspnea) is not. The investigators have shown that dyspnea was not a common presenting complaint in a large UK series, and that there is little correlation between severity of dyspnea in PAVM patients, and blood oxygen levels.
In this study the investigators will address the question "Do PAVM patients have lower exercise tolerance if they have concurrent airflow obstruction?" The primary outcome measure will be the total body oxygen consumption in mls/min/kg, at peak exercise (the V[dot]O2 peak (also known as "VO2 max")).
The investigators will address this by first performing standardised cardiopulmonary exercise testing, as used in the clinic and our previous study (11/H0803/9), on age and sex matched patients with PAVMs. 30 will be recruited with airflow obstruction, and 30 without airflow obstruction. Physiological parameters will be compared, to test the null hypothesis that the impact of exercise on PAVM patients' cardiopulmonary systems does not differ according to the presence or absence of airflow obstruction. Cellular and molecular methods will be used to dissect mechanistic pathways.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arteriovenous Malformations, Hereditary Hemorrhagic Telangiectasia, Asthma, COPD
Keywords
workload, oxygen level, oxygen consumption, breathing reserve, ventilatory efficiency
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with pulmonary AVMs and no airflow obstruction
Arm Type
Experimental
Arm Description
30 patients with pulmonary AVMs and no airflow obstruction will undergo cardiopulmonary exercise testing
Arm Title
Patients with pulmonary AVMs and airflow obstruction
Arm Type
Experimental
Arm Description
30 patients with pulmonary AVMs and airflow obstruction will undergo cardiopulmonary exercise testing
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary exercise test
Other Intervention Name(s)
CPET
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total body oxygen consumption in mls/min/kg, at peak exercise (VO2 max).
Description
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."
Time Frame
Same day (within 1 hour), at end of exercise study
Secondary Outcome Measure Information:
Title
Breathing reserve
Description
We will also test in univariate and multiple regression analyses whether breathing reserve differs between PAVM patients with and without airflow obstruction.
Time Frame
Same day (within 1 hour), at end of exercise study
Title
Ventilatory efficiency
Description
We will also test in univariate and multiple regression analyses whether ventilatory efficiency differs between PAVM patients with and without airflow obstruction.
Time Frame
Same day (within 1 hour), at end of exercise study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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%).
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire L Shovlin, PhD FRCP
Phone
44 208 282 2352
Email
c.shovlin@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Luke Howard, DPhil FRCP
Phone
44 208 282 2352
Email
l.howard@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire L Shovlin, PhD FRCP
Organizational Affiliation
Hammersmith Hospital, Du Cane Rd, London, United Kingdom, W12 0NN
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24676541
Citation
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.
Results Reference
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Cardiopulmonary Exercise Testing to Evaluate Pulmonary AVMs With and Without Airflow Obstruction
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