Left Ventricular Systolic DysfunctionPVANCT01162083
Identifying an Ideal Cardiopulmonary Exercise Test Parameter
An observational study of Left Ventricular Systolic Dysfunction and Mitral Regurgitation, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Cardiopulmonary exercise testing (CPET) is a safe, noninvasive investigation where a patient walks on a treadmill or cycles whilst attached to an ECG and with a mask that measures the air breathed in and out. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Systolic Dysfunction, Mitral Regurgitation
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to May 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Current patients under tertiary care for cardiac or respiratory disease. Valvular patients will be stable patients under follow-up to judge optimal timing for intervention on clinical grounds at which point they will become applicable to the study.
Who may be able to join
- Aged over 18 years of age.
- Able to perform cycle ergometry and agree to perform between 2 and 3 tests.
- If previously undergone echocardiography there is evidence of reasonable echo windows (good views).
- Agree to the full study protocol.
Who cannot join
- Significant coexistent pathologies of the groups tested unless specifically in that group of mixed pathologies in the "Observational Study". This includes any combination of COPD or restrictive lung disease alongside heart failure and valvular disease. Therefore all cardiac conditions should have no significant limitation on spirometry, and all patients with lung disease should have good left ventricular function with no significant increases in pulmonary vascular pressures as seen on echocardiography. Patients with atrial fibrillation/ flutter will be excluded. Patients with more than mild valvular lesions will be excluded from all groups except the joint group and the group with mitral valvular disease
- Symptomatic coronary disease, or significant ischaemia noted on cardiopulmonary exercise test (unless accounted for by aortic valve disease, in which case a prior coronary angiogram would have been undertaken if significant coronary disease then they will not be invited to participate).
- Anaemia (Hb <12 in men, <11 in women).
- Obesity (BMI >30) which could lead to limitation independent of the cardiovascular or respiratory condition.
- Chronic Kidney Disease Stage 3 or above (estimated GFR <60ml/hr as calculated by Cockcroft Gault equation). The metabolic acidosis associated with this condition will affect ventilatory equivalents.
- Poor echocardiographic windows so that a full data set is not achievable.
Show all 18Show fewer
- Inability to perform a symptom limited cardiopulmonary exercise test.
- Inability to perform spirometry.
- Inability to consent/make decisions (lack of competence)
- Vulnerable adult/current detainee in prison/elsewhere.
- Significant neurological or musculoskeletal abnormalities.
- Inability to complete all the investigations at the time intervals agreed in the protocol.
- Permanent Pacemaker unless in the biventricular pacemaker group in the Interventional Study. These patients in this group will be excluded if they are pacing dependent (when the biventricular function is disabled they do not have a normal intrinsic rhythm) and if they have significant first degree AV block at rest or on exercise (will activate right ventricular pacing after a sinus beat).
- Patients in the atrial fibrillation interventional group will be excluded if they revert back to atrial fibrillation after the procedure, or the procedure never restores sinus rhythm. These patients will still be eligible for inclusion in the observational study.
- Recent (recovery within <1month) decompensation of their underlying cardiac or respiratory disorder.
- Uncontrolled hypertension.
- Untreated life threatening arrhythmia.
- Recent surgery (within 10 weeks).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W2 1LA
About this study
Official title: Identifying the Ideal Parameter of the Cardiopulmonary Exercise Test to Distinguish Between the Cardiovascular and Respiratory Components of Functional Limitation and to Detect Relevant Physiological Changes in Function
Cardiopulmonary exercise testing (CPET) is a safe, noninvasive investigation where a patient walks on a treadmill or cycles whilst attached to an ECG and with a mask that measures the air breathed in and out. It has numerous clinical uses, such as diagnosing the main cause in patients with breathlessness, deciding on timing for heart transplantation and assessing whether patients are safe for a general anaesthetic.
A patient's peak oxygen consumption, the maximum amount of oxygen taken up by the blood from the lungs when breathing increases during exercise, is the main measurement taken from CPET. It is low in heart disease and has been used to predict the risk of death and therefore plan treatments for patients. However this is also low in numerous other diseases including lung disease; reduced oxygen consumption in patients with two conditions may be wrongly thought to be because of the heart leading to inappropriate action and distress to the patient.
Read more
Newer measurements of exercise capacity from the same exercise test are better at predicting death in heart failure.
We propose that they are more specific for heart failure over other diseases, for example lung disease, when compared with peak oxygen consumption, and are superior when a single best test for heart failure is required.
This research aims to identify which measurement of exercise capacity is most specific for heart failure. We will perform the test on many patients with different diseases, and before and after procedures such as the implantation of special pacemakers, and heart valve operations. This should lead to a more accepted use of this investigation and the more appropriate identification of which patient should have which procedure.
Read the detailed description
Heart failure, where the heart muscle is damaged and is unable to pump blood efficiently, affects 9% of those aged 55 or more and is responsible for about 2% of the hospital admissions in the UK. The first symptom many patients complain of is breathlessness on exercise and an inability to perform their normal daily activities. Unfortunately these symptoms are similar to those experienced in numerous diseases of the heart and lungs. Cardiopulmonary exercise testing, through measuring numerous values taken from breathing during exercise can tell us which disease is causing the symptoms.
The leading parameter from a CPET, peak VO2, has for many years been the single value used to guide management of patients following a diagnosis of many diseases from the heart and lungs. Newer measures predict outcome from heart failure (our principal area of interest) better. We believe this may be because they are less affected by lung disease than peak VO2 and we know that many patients have both heart and lung diseases.
By showing the best CPET variable for each individual disease state, we will be able to ensure patients are correctly put into a level of risk for their condition and that they will be followed-up with the most accurate marker from exercise testing, rather than a "one size fits all" approach of peak VO2.
With regards to heart valve disease, standard exercise testing just using ECG leads, rather than cardiopulmonary exercise testing, is starting to be used more in identifying patients without symptoms for possible surgery. The inaccuracy of this test will inevitably lead to patients being wrongly categorised. Cardiopulmonary exercise testing is a much more accurate way of establishing the impact of any disease on the heart or lung over traditional exercise testing and therefore we believe that evidence of its role around the time of surgery could be used as further support for its role in improving decision making for patient.
Ultimately the greater knowledge of this test and when we should use it will help patients with very common heart conditions to be treated appropriately, potentially helping many patients.
- Keywords
- Exercise Physiology, Cardiopulmonary Interaction, Heart Failure
- Medical subject headings
- Ventricular Dysfunction, Left, Mitral Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mitral Valve disease | Patients with mitral valve disease, deemed suitable and ready for elective valve repair or replacement. No significant arrhythmias, other valvular disease or LV dysfunction present. We shall also be recruiting patients undergoing a Mitraclip procedure. | |
| COPD | Patients with isolated chronic obstructive pulmonary disease and no cardiac disease. | |
| Mixed Lesions | Patients with proven limitation from both cardiac and respiratory disease. | |
| CRT | Patients with symptomatic heart failure who have responded to cardiac resynchronisation therapy (biventricular pacemaker). | |
| Cardiomyopathy | Heart Failure of primarily myopathic origin, without rhythm disturbance, ongoing ischaemia or significant valvular disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relation or change between Cardiopulmonary exercise test variables
In the Observational Cohort Study the primary outcome measure is the relation between variables (peak VO2, VE/VCO2, OUES, Tau, AT) when compared between the groups with different disease states.
In the Interventional Cohort Study the primary outcome is the change in a variable (peak VO2, VE/VCO2, OUES, Tau, AT) from before to after an intervention which is required on clinical grounds.
Measured: Up to 6 months
Secondary outcomes (1)
Using Cardiopulmonary Exercise Test Variables to help Assess for Functional Improvement
In patients undergoing heart valve replacements or an ablation for atrial fibrillation the improvement in symptomatic benefit will be compared to the change in cardiopulmonary exercise test variables.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2013
- Study completionMay 2013
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 Left Ventricular Systolic DysfunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Humboldt-Universität zu Berlin, British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Roland Wensel, MD PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162083
- Sponsor's protocol ID
- CRO1570
- Acronym
- PVA
- Status last verified
- Aug 2011
- First submitted
- 13 Jul 2010
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Barron A, Francis DP, Mayet J, Ewert R, Obst A, Mason M, Elkin S, Hughes AD, Wensel R. Oxygen Uptake Efficiency Slope and Breathing Reserve, Not Anaerobic Threshold, Discriminate Between Patients With Cardiovascular Disease Over Chronic Obstructive Pulmonary Disease. JACC Heart Fail. 2016 Apr;4(4):252-61. doi: 10.1016/j.jchf.2015.11.003. Epub 2016 Feb 10.
PubMed 26874378
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Ideal Parameter of the Cardiopulmonary Exercise Test to Distinguish Between the Cardiovascular and Respiratory Components of Functional Limitation and to Detect Relevant Physiological Changes in Function
- ClinicalTrials.gov ID
- NCT01162083
- Acronym / sponsor ID
- PVA / CRO1570
- Keywords
- Exercise Physiology, Cardiopulmonary Interaction, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Humboldt-Universität zu Berlin, British Heart Foundation
- Study start
- Oct 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Jul 2010 (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.
Cardiopulmonary exercise testing (CPET) is a safe, noninvasive investigation where a patient walks on a treadmill or cycles whilst attached to an ECG and with a mask that measures the air breathed in and out. It has numerous clinical uses, such as diagnosing the main cause in patients with breathlessness, deciding on timing for heart transplantation and assessing whether patients are safe for a general anaesthetic.
A patient's peak oxygen consumption, the maximum amount of oxygen taken up by the blood from the lungs when breathing increases during exercise, is the main measurement taken from CPET. It is low in heart disease and has been used to predict the risk of death and therefore plan treatments for patients. However this is also low in numerous other diseases including lung disease; reduced oxygen consumption in patients with two conditions may be wrongly thought to be because of the heart leading to inappropriate action and distress to the patient.
Newer measurements of exercise capacity from the same exercise test are better at predicting death in heart failure.
We propose that they are more specific for heart failure over other diseases, for example lung disease, when compared with peak oxygen consumption, and are superior when a single best test for heart failure is required.
This research aims to identify which measurement of exercise capacity is most specific for heart failure. We will perform the test on many patients with different diseases, and before and after procedures such as the implantation of special pacemakers, and heart valve operations. This should lead to a more accepted use of this investigation and the more appropriate identification of which patient should have which procedure.
Detailed description
Heart failure, where the heart muscle is damaged and is unable to pump blood efficiently, affects 9% of those aged 55 or more and is responsible for about 2% of the hospital admissions in the UK. The first symptom many patients complain of is breathlessness on exercise and an inability to perform their normal daily activities. Unfortunately these symptoms are similar to those experienced in numerous diseases of the heart and lungs. Cardiopulmonary exercise testing, through measuring numerous values taken from breathing during exercise can tell us which disease is causing the symptoms.
The leading parameter from a CPET, peak VO2, has for many years been the single value used to guide management of patients following a diagnosis of many diseases from the heart and lungs. Newer measures predict outcome from heart failure (our principal area of interest) better. We believe this may be because they are less affected by lung disease than peak VO2 and we know that many patients have both heart and lung diseases.
By showing the best CPET variable for each individual disease state, we will be able to ensure patients are correctly put into a level of risk for their condition and that they will be followed-up with the most accurate marker from exercise testing, rather than a "one size fits all" approach of peak VO2.
With regards to heart valve disease, standard exercise testing just using ECG leads, rather than cardiopulmonary exercise testing, is starting to be used more in identifying patients without symptoms for possible surgery. The inaccuracy of this test will inevitably lead to patients being wrongly categorised. Cardiopulmonary exercise testing is a much more accurate way of establishing the impact of any disease on the heart or lung over traditional exercise testing and therefore we believe that evidence of its role around the time of surgery could be used as further support for its role in improving decision making for patient.
Ultimately the greater knowledge of this test and when we should use it will help patients with very common heart conditions to be treated appropriately, potentially helping many patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Mitral Valve disease | – | –Patients with mitral valve disease, deemed suitable and ready for elective valve repair or replacement. No significant arrhythmias, other valvular disease or LV dysfunction present. We shall also be recruiting patients undergoing a Mitraclip procedure. |
| COPD | – | –Patients with isolated chronic obstructive pulmonary disease and no cardiac disease. |
| Mixed Lesions | – | –Patients with proven limitation from both cardiac and respiratory disease. |
| CRT | – | –Patients with symptomatic heart failure who have responded to cardiac resynchronisation therapy (biventricular pacemaker). |
| Cardiomyopathy | – | –Heart Failure of primarily myopathic origin, without rhythm disturbance, ongoing ischaemia or significant valvular disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Current patients under tertiary care for cardiac or respiratory disease. Valvular patients will be stable patients under follow-up to judge optimal timing for intervention on clinical grounds at which point they will become applicable to the study.
Key inclusion criteria (4 listed)
- Aged over 18 years of age.
- Able to perform cycle ergometry and agree to perform between 2 and 3 tests.
- If previously undergone echocardiography there is evidence of reasonable echo windows (good views).
- Agree to the full study protocol.
Key exclusion criteria (18 listed)
- Significant coexistent pathologies of the groups tested unless specifically in that group of mixed pathologies in the "Observational Study". This includes any combination of COPD or restrictive lung disease alongside heart failure and valvular disease. Therefore all cardiac conditions should have no significant limitation on spirometry, and all patients with lung disease should have good left ventricular function with no significant increases in pulmonary vascular pressures as seen on echocardiography. Patients with atrial fibrillation/ flutter will be excluded. Patients with more than mild valvular lesions will be excluded from all groups except the joint group and the group with mitral valvular disease
- Symptomatic coronary disease, or significant ischaemia noted on cardiopulmonary exercise test (unless accounted for by aortic valve disease, in which case a prior coronary angiogram would have been undertaken if significant coronary disease then they will not be invited to participate).
- Anaemia (Hb <12 in men, <11 in women).
- Obesity (BMI >30) which could lead to limitation independent of the cardiovascular or respiratory condition.
- Chronic Kidney Disease Stage 3 or above (estimated GFR <60ml/hr as calculated by Cockcroft Gault equation). The metabolic acidosis associated with this condition will affect ventilatory equivalents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The relation or change between Cardiopulmonary exercise test variables
Time frame: Up to 6 months
In the Observational Cohort Study the primary outcome measure is the relation between variables (peak VO2, VE/VCO2, OUES, Tau, AT) when compared between the groups with different disease states. In the Interventional Cohort Study the primary outcome is the change in a variable (peak VO2, VE/VCO2, OUES, Tau, AT) from before to after an intervention which is required on clinical grounds.
1 secondary outcome
Using Cardiopulmonary Exercise Test Variables to help Assess for Functional Improvement
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Derived from this study: PubMed 26874378Barron A, Francis DP, Mayet J, Ewert R, Obst A, Mason M, Elkin S, Hughes AD, Wensel R. Oxygen Uptake Efficiency Slope and Breathing Reserve, Not Anaerobic Threshold, Discriminate Between Patients With Cardiovascular Disease Over Chronic Obstructive Pulmonary Disease. JACC Heart Fail. 2016 Apr;4(4):252-61. doi: 10.1016/j.jchf.2015.11.003. Epub 2016 Feb 10.
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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.
Roland Wensel, MD PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Systolic Dysfunction and Mitral Regurgitation, run by Imperial College London at 1 site in United Kingdom.
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 4 inclusion and 18 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: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relation or change between Cardiopulmonary exercise test variables (time frame: Up to 6 months). 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 NCT01162083, 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 17 Feb 2016.