Pulmonary HypertensionCMR-CPETNCT04729777
Assessment of Cardiac Function Using Combined Cardiovascular Magnetic Resonance and Cardiopulmonary Exercise Testing (CMR-CPET)
An observational study of Pulmonary Hypertension, run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
What problems limit patients' response to exercise? Using exercise cardiac magnetic resonance imaging to assess the heart's response, with simultaneous measurement of respiratory oxygen and carbon dioxide levels to assess the lung and skeletal muscle responses, to identify the rate-limiting factors affecting different… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Combined Cardiovascular Magnetic Resonance and Cardiopulmonary Exercise Testing
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2019to 1 Oct 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 - 80 years with symptoms of breathlessness on exertion, and under the care of cardiology, pulmonary hypertension or rheumatology clinics for non-ischaemic cardiovascular disease.
Who may be able to join
- Age 18-80 years
- Symptoms of breathlessness on exertion under the care of cardiology, pulmonary hypertension or rheumatology clinics for non-ischaemic cardiovascular disease
- Willing and able to provide written informed consent
Who cannot join
- Previous ischaemic heart disease (including angina, myocardial infarction, PCI, CABG)
- Unstable symptoms (including crescendo angina or angina at rest, and syncope on exercise)*
- Arrhythmia**
- Musculoskeletal disease preventing exercise
- Patients unable to provide consent
- General contraindications to CMR (e.g. implanted metal objects, pregnancy, severe claustrophobia)
- Significant parenchymal lung disease (defined as >20% extent parenchymal disease on CT)
- WHO functional class IV symptoms *Patients with unstable symptoms have been excluded as it would be unsafe for them to perform exercise whilst in a MRI scanner. Patients unable to exercise, WHO functional class IV and those with significant lung disease have been excluded as they would be unable to complete the exercise protocol **The researchers have excluded patients with arrhythmia as this can reduce the reliability of some of the CMR image sequences and also results in less predictable heart rate response to exercise
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Free Hospital NHS Foundation Trust
London, NW3 2QG
James Brown, +44 (0)2074332780, james.brown1@nhs.net
Daniel Knight
About this study
What problems limit patients' response to exercise? Using exercise cardiac magnetic resonance imaging to assess the heart's response, with simultaneous measurement of respiratory oxygen and carbon dioxide levels to assess the lung and skeletal muscle responses, to identify the rate-limiting factors affecting different types of patient
Read the detailed description
Background and study aims Many medical conditions that affect the heart and lungs can cause breathlessness. People affected by breathlessness often require a number of tests to diagnose the medical condition responsible for their symptoms.
Cardiac MRI (magnetic resonance) scanning is already used to help diagnose and monitor patients with heart conditions (for example cardiomyopathy and pulmonary hypertension). By exercising while having an MRI scan, and at the same time measuring the gases breathed in and out from the air, it will be possible to more accurately understand the changes that occur in the heart, lungs and muscles.
The purpose of this study is to develop our understanding of the cardiovascular response to exercise in patients with non-ischaemic cardiomyopathy.
Who can participate? Patients aged 18 - 80 years with symptoms of breathlessness on exertion, and under the care of cardiology, pulmonary hypertension or rheumatology clinics for non-ischaemic cardiovascular disease.
What does the study involve? Participants will be invited to an appointment at the cardiovascular MRI department at the Royal Free Hospital. On the day of the appointment, participants will be welcomed to the department by the research team and the researchers will check that participants are well enough to exercise and safe to have an MRI scan. There will be an opportunity to ask any further questions.
The researchers will ask participants to perform exercise in one of three ways:
- Using our special MRI safe exercise bike: The researchers will show participants how to use this and then the researchers will help participants to get on it and into the MRI scanner.
- Lifting a weight using their arms: The researchers will check how much weight participants would be expected to manage before participants enter the scanner. The researchers will ask participants to lift and hold a weight using their dominant arm during the scan.
- Stepping one (or both) leg(s) using an elastic resistance band. The researchers will measure the band so it is of the appropriate length for participants, and the researchers will show participants how to perform the exercise when in the scanner.
The researchers will give participants a special face mask to wear to measure the concentration of gases in exhaled breath (like carbon dioxide or oxygen) and breathing volumes. Most adults and children find the face mask comfortable and easy to wear.
The researchers will give participants a head-set so that participants can communicate at all times with the person running the scan.
First participants will have a MRI scan where the researchers ask participants to lie back and relax (this will take about 30 minutes).
Then the researchers will ask participants to exercise on the MRI safe bike for about 7 minutes, lift the weight for about 3 minutes, or perform leg stepping for about 3 minutes whilst participants are having continuous MRI scanning.
After the scan, the researchers will help participants out of the scanner.
What are the possible benefits and risks of participating? There are no individual benefits to taking part. The researchers hope that information from this study will help improve the understanding and treatment of heart conditions that can limit exercise ability. If participants like the researchers can make participants a copy of their scan on CD to keep. Sometimes the researchers might find new information that the researchers need to tell their treating doctor straight away. If the researchers do find such information the researchers will let participants and their doctor know as soon as possible. The researchers will reimburse reasonable travel expenses for participants to attend the research scan (unless participants are already scheduled to have a clinical visit on the same day). MRI scanning is very safe.
- Conditions
- Pulmonary Hypertension
- Being tested
- Combined Cardiovascular Magnetic Resonance and Cardiopulmonary Exercise Testing
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Cardiovascular Magnetic Resonance and Cardiopulmonary Exercise TestingProcedure or surgery
Clinical Cardiac MRI scan at rest with routine administration of gadolinium contrast agent. Participants then undergo the research component of the test which requires them to perform exercise, using a recumbent, MRI-compatible cycle ergometer, whilst their breathing is simultaneously analysed using a mask connected to a CPET machine, until they are limited by symptoms and they stop pedalling. Most participants will undergo only one scan. Some participants will be asked to have two or three such scans over 3 months to assess changes over time, and in response to standard treatment of pulmonary hypertension.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output (L/min) measured using aortic flow from PCMR measurements
Cardiac output (L/min) measured using aortic flow from PCMR measurements measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Measured: Change from Baseline at 3 months
Ventricular volumes (mL) measured using volumetric measurements of both ventricles, at end-diastole and end-systole
Ventricular volumes (mL) measured using volumetric measurements of both ventricles, at end-diastole and end-systole measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Measured: Change from Baseline at 3 months
Heart rate (bpm) from MRI ECG/heart rate monitor
Heart rate (bpm) from MRI ECG/heart rate monitor measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Measured: Change from Baseline at 3 months
Blood pressure (mmHg) from MRI-compatible BP monitor
Blood pressure (mmHg) from MRI-compatible BP monitor measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Measured: Change from Baseline at 3 months
Oxygen consumption (VO2, mL/min) from CPET machine
Oxygen consumption (VO2, mL/min) from CPET machine measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Measured: Change from Baseline at 3 months
Carbon dioxide production (VCO2, mL/min) from CPET machine
Carbon dioxide production (VCO2, mL/min) from CPET machine measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Measured: Change from Baseline at 3 months
Arteriovenous Oxygen Gradient (Muscle oxygen consumption, mlO2/100mL blood/min) calculated from Cardiac Output and VO2
Arteriovenous Oxygen Gradient (Muscle oxygen consumption, mlO2/100mL blood/min) measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise calculated from Cardiac Output and VO2
Measured: Change from Baseline at 3 months
Respiratory exchange ratio (RER) from CPET machine
Respiratory exchange ratio (RER) from CPET machine measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Measured: Change from Baseline at 3 months
Exercise duration (sec) measured using a timer from the start to the end of exercise
Exercise duration (sec) measured using a timer from the start to the end of exercise measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Measured: Change from Baseline at 3 months
Secondary outcomes (7)
Cardiac Troponin T (ng/L) measured using blood sample prior to scan
Cardiac Troponin T (ng/L) measured using blood sample prior to scan and after scan
Measured: through study completion, an average of 1 year
N-terminal pro-BNP (ng/L) measured using blood sample prior to scan
N-terminal pro-BNP (ng/L) measured using blood sample prior to scan and after scan
Measured: through study completion, an average of 1 year
Haemoglobin (g/L) measured using blood sample prior to scan
Haemoglobin (g/L) measured using blood sample prior to scan and after scan
Measured: through study completion, an average of 1 year
Autoantibody profile measured using blood sample prior to scan
Autoantibody profile measured using blood sample prior to scan and after scan
Measured: through study completion, an average of 1 year
Invasive pulmonary pressures (PA systolic/diastolic/mean) in MR-RHC substudy measured using a pressure transducer at rest and after 1 min of exercise
Invasive pulmonary pressures (PA systolic/diastolic/mean) in MR-RHC substudy measured using a pressure transducer at rest and after 1 min of exercise
Measured: through study completion, an average of 1 year
PH disease progression (WHO Functional class) measured using patient records
PH disease progression (WHO Functional class) measured using patient records
Measured: Change from baseline at 6 months
Mortality measured using patient records
Mortality measured using patient records
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Mar 2019
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion, British Heart Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729777
- Sponsor's protocol ID
- 100358
- Other IDs
- 226101
- Acronym
- CMR-CPET
- Status last verified
- Jan 2021
- First submitted
- 12 Jul 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data generated or analysed during this study will be included in the subsequent results publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiac Function Using Combined Cardiovascular Magnetic Resonance and Cardiopulmonary Exercise Testing (CMR-CPET)
- ClinicalTrials.gov ID
- NCT04729777
- Acronym / sponsor ID
- CMR-CPET / 100358
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Actelion, British Heart Foundation
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 28 Jan 2021 (actual)
- 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.
What problems limit patients' response to exercise? Using exercise cardiac magnetic resonance imaging to assess the heart's response, with simultaneous measurement of respiratory oxygen and carbon dioxide levels to assess the lung and skeletal muscle responses, to identify the rate-limiting factors affecting different types of patient
Detailed description
Background and study aims Many medical conditions that affect the heart and lungs can cause breathlessness. People affected by breathlessness often require a number of tests to diagnose the medical condition responsible for their symptoms.
Cardiac MRI (magnetic resonance) scanning is already used to help diagnose and monitor patients with heart conditions (for example cardiomyopathy and pulmonary hypertension). By exercising while having an MRI scan, and at the same time measuring the gases breathed in and out from the air, it will be possible to more accurately understand the changes that occur in the heart, lungs and muscles.
The purpose of this study is to develop our understanding of the cardiovascular response to exercise in patients with non-ischaemic cardiomyopathy.
Who can participate? Patients aged 18 - 80 years with symptoms of breathlessness on exertion, and under the care of cardiology, pulmonary hypertension or rheumatology clinics for non-ischaemic cardiovascular disease.
What does the study involve? Participants will be invited to an appointment at the cardiovascular MRI department at the Royal Free Hospital. On the day of the appointment, participants will be welcomed to the department by the research team and the researchers will check that participants are well enough to exercise and safe to have an MRI scan. There will be an opportunity to ask any further questions.
The researchers will ask participants to perform exercise in one of three ways:
- Using our special MRI safe exercise bike: The researchers will show participants how to use this and then the researchers will help participants to get on it and into the MRI scanner.
- Lifting a weight using their arms: The researchers will check how much weight participants would be expected to manage before participants enter the scanner. The researchers will ask participants to lift and hold a weight using their dominant arm during the scan.
- Stepping one (or both) leg(s) using an elastic resistance band. The researchers will measure the band so it is of the appropriate length for participants, and the researchers will show participants how to perform the exercise when in the scanner.
The researchers will give participants a special face mask to wear to measure the concentration of gases in exhaled breath (like carbon dioxide or oxygen) and breathing volumes. Most adults and children find the face mask comfortable and easy to wear.
The researchers will give participants a head-set so that participants can communicate at all times with the person running the scan.
First participants will have a MRI scan where the researchers ask participants to lie back and relax (this will take about 30 minutes).
Then the researchers will ask participants to exercise on the MRI safe bike for about 7 minutes, lift the weight for about 3 minutes, or perform leg stepping for about 3 minutes whilst participants are having continuous MRI scanning.
After the scan, the researchers will help participants out of the scanner.
What are the possible benefits and risks of participating? There are no individual benefits to taking part. The researchers hope that information from this study will help improve the understanding and treatment of heart conditions that can limit exercise ability. If participants like the researchers can make participants a copy of their scan on CD to keep. Sometimes the researchers might find new information that the researchers need to tell their treating doctor straight away. If the researchers do find such information the researchers will let participants and their doctor know as soon as possible. The researchers will reimburse reasonable travel expenses for participants to attend the research scan (unless participants are already scheduled to have a clinical visit on the same day). MRI scanning is very safe.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 - 80 years with symptoms of breathlessness on exertion, and under the care of cardiology, pulmonary hypertension or rheumatology clinics for non-ischaemic cardiovascular disease.
Key inclusion criteria (3 listed)
- Age 18-80 years
- Symptoms of breathlessness on exertion under the care of cardiology, pulmonary hypertension or rheumatology clinics for non-ischaemic cardiovascular disease
- Willing and able to provide written informed consent
Key exclusion criteria (8 listed)
- Previous ischaemic heart disease (including angina, myocardial infarction, PCI, CABG)
- Unstable symptoms (including crescendo angina or angina at rest, and syncope on exercise)*
- Arrhythmia**
- Musculoskeletal disease preventing exercise
- Patients unable to provide consent
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 |
|---|---|---|
| Combined Cardiovascular Magnetic Resonance and Cardiopulmonary Exercise TestingClinical Cardiac MRI scan at rest with routine administration of gadolinium contrast agent. Participants then undergo the research component of the test which requires them to perform exercise, using a recumbent, MRI-compatible cycle ergometer, whilst their breathing is simultaneously analysed using a mask connected to a CPET machine, until they are limited by symptoms and they stop pedalling. Most participants will undergo only one scan. Some participants will be asked to have two or three such scans over 3 months to assess changes over time, and in response to standard treatment of pulmonary hypertension. | Procedure or surgery | – |
Primary outcome
Cardiac output (L/min) measured using aortic flow from PCMR measurements
Time frame: Change from Baseline at 3 months
Cardiac output (L/min) measured using aortic flow from PCMR measurements measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Ventricular volumes (mL) measured using volumetric measurements of both ventricles, at end-diastole and end-systole
Time frame: Change from Baseline at 3 months
Ventricular volumes (mL) measured using volumetric measurements of both ventricles, at end-diastole and end-systole measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Heart rate (bpm) from MRI ECG/heart rate monitor
Time frame: Change from Baseline at 3 months
Heart rate (bpm) from MRI ECG/heart rate monitor measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Blood pressure (mmHg) from MRI-compatible BP monitor
Time frame: Change from Baseline at 3 months
Blood pressure (mmHg) from MRI-compatible BP monitor measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Oxygen consumption (VO2, mL/min) from CPET machine
Time frame: Change from Baseline at 3 months
Oxygen consumption (VO2, mL/min) from CPET machine measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Carbon dioxide production (VCO2, mL/min) from CPET machine
Time frame: Change from Baseline at 3 months
Carbon dioxide production (VCO2, mL/min) from CPET machine measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Arteriovenous Oxygen Gradient (Muscle oxygen consumption, mlO2/100mL blood/min) calculated from Cardiac Output and VO2
Time frame: Change from Baseline at 3 months
Arteriovenous Oxygen Gradient (Muscle oxygen consumption, mlO2/100mL blood/min) measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise calculated from Cardiac Output and VO2
Respiratory exchange ratio (RER) from CPET machine
Time frame: Change from Baseline at 3 months
Respiratory exchange ratio (RER) from CPET machine measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Exercise duration (sec) measured using a timer from the start to the end of exercise
Time frame: Change from Baseline at 3 months
Exercise duration (sec) measured using a timer from the start to the end of exercise measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
7 secondary outcomes
Cardiac Troponin T (ng/L) measured using blood sample prior to scan
Time frame: through study completion, an average of 1 year
N-terminal pro-BNP (ng/L) measured using blood sample prior to scan
Time frame: through study completion, an average of 1 year
Haemoglobin (g/L) measured using blood sample prior to scan
Time frame: through study completion, an average of 1 year
Autoantibody profile measured using blood sample prior to scan
Time frame: through study completion, an average of 1 year
Invasive pulmonary pressures (PA systolic/diastolic/mean) in MR-RHC substudy measured using a pressure transducer at rest and after 1 min of exercise
Time frame: through study completion, an average of 1 year
PH disease progression (WHO Functional class) measured using patient records
Time frame: Change from baseline at 6 months
Mortality measured using patient records
Time frame: Change from baseline at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: Yes. All data generated or analysed during this study will be included in the subsequent results publication
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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.
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 Pulmonary Hypertension, run by Royal Free Hospital NHS Foundation Trust 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 3 inclusion and 8 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 28 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Brown (+44 (0)2074332780, james.brown1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (L/min) measured using aortic flow from PCMR measurements (time frame: Change from Baseline at 3 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2021.