Pulmonary Arteriovenous MalformationsExercisePAVM2NCT02458703
Cardiopulmonary Exercise Testing to Evaluate Pulmonary AVMs With and Without Airflow Obstruction
A study testing Cardiopulmonary exercise test in people with Pulmonary Arteriovenous Malformations and Hereditary Hemorrhagic Telangiectasia, run by Imperial College London.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Pulmonary Arteriovenous Malformations, Hereditary Hemorrhagic Telangiectasia, Asthma
- What is being tested?
- Cardiopulmonary exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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%).
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Hypoxemia, Dyspnea, and Exercise Tolerance in Patients With Pulmonary Arteriovenous Malformations , With and Without Airflow Obstruction
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.
Read the 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.
- Conditions
- Pulmonary Arteriovenous Malformations, Hereditary Hemorrhagic Telangiectasia, Asthma, COPD
- Being tested
- Cardiopulmonary exercise test
- Keywords
- workload, oxygen level, oxygen consumption, breathing reserve, ventilatory efficiency
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic, Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testOther
Also called CPET
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pulmonary AVMs and no airflow obstruction | Experimental | 30 patients with pulmonary AVMs and no airflow obstruction will undergo cardiopulmonary exercise testing Receives: Other: Cardiopulmonary exercise test |
| Patients with pulmonary AVMs and airflow obstruction | Experimental | 30 patients with pulmonary AVMs and airflow obstruction will undergo cardiopulmonary exercise testing Receives: Other: Cardiopulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Same day (within 1 hour), at end of exercise study
Secondary outcomes (2)
Breathing reserve
We will also test in univariate and multiple regression analyses whether breathing reserve differs between PAVM patients with and without airflow obstruction.
Measured: Same day (within 1 hour), at end of exercise study
Ventilatory efficiency
We will also test in univariate and multiple regression analyses whether ventilatory efficiency differs between PAVM patients with and without airflow obstruction.
Measured: Same day (within 1 hour), at end of exercise study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arteriovenous MalformationsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire L Shovlin, PhD FRCP, Principal investigator, Hammersmith Hospital, Du Cane Rd, London, United Kingdom, W12 0NN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458703
- Sponsor's protocol ID
- CLS 2015/1
- Other IDs
- 15/LO/0598
- Acronym
- ExercisePAVM2
- Status last verified
- Apr 2015
- First submitted
- 28 May 2015
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24676541
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxemia, Dyspnea, and Exercise Tolerance in Patients With Pulmonary Arteriovenous Malformations , With and Without Airflow Obstruction
- ClinicalTrials.gov ID
- NCT02458703
- Acronym / sponsor ID
- ExercisePAVM2 / CLS 2015/1
- Conditions
- Pulmonary Arteriovenous Malformations, Hereditary Hemorrhagic Telangiectasia, Asthma, COPD
- Keywords
- workload, oxygen level, oxygen consumption, breathing reserve, ventilatory efficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pulmonary AVMs and no airflow obstruction | Experimental | Other: Cardiopulmonary exercise test30 patients with pulmonary AVMs and no airflow obstruction will undergo cardiopulmonary exercise testing |
| Patients with pulmonary AVMs and airflow obstruction | Experimental | Other: Cardiopulmonary exercise test30 patients with pulmonary AVMs and airflow obstruction will undergo cardiopulmonary exercise testing |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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%).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary exercise testAlso: CPETSubjects 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. | Other | Patients with pulmonary AVMs and airflow obstruction, Patients with pulmonary AVMs and no airflow obstruction |
Primary outcome
Total body oxygen consumption in mls/min/kg, at peak exercise (VO2 max).
Time frame: Same day (within 1 hour), at end of exercise study
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."
2 secondary outcomes
Breathing reserve
Time frame: Same day (within 1 hour), at end of exercise study
Ventilatory efficiency
Time frame: Same day (within 1 hour), at end of exercise study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Background: PubMed 24676541Howard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire L Shovlin, PhD FRCP principal investigator
Hammersmith Hospital, Du Cane Rd, London, United Kingdom, W12 0NN
Questions about this trial
What is this clinical trial studying?
A study testing Cardiopulmonary exercise test in people with Pulmonary Arteriovenous Malformations and Hereditary Hemorrhagic Telangiectasia, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire L Shovlin, PhD FRCP (44 208 282 2352, c.shovlin@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total body oxygen consumption in mls/min/kg, at peak exercise (VO2 max). (time frame: Same day (within 1 hour), at end of exercise study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02458703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2015; AzTrials last refreshed its copy on 30 Oct 2026.