Cardiovascular Risk FactorNCT04312802
Cardiopulmonary Testing for Potential Pancreas Transplant Candidates
An observational study of Cardiovascular Risk Factor and Diabetes Mellitus, Type 1, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Patients being assessed for Kidney Pancreas transplantation often have pre-existing co-morbid disease that contributes to structural cardiac and vascular disease. There is no consensus on optimal pre-listing cardiac assessment to reliably minimize risk of peri-operative cardiac events. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiovascular Risk Factor, Diabetes Mellitus, Type 1, Pancreas Transplant; Complications
- What is being tested?
- Cardiopulmonary exercise test (CPET)
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2018to 14 Sep 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with type 1 diabetes mellitus and impaired kidney function being assessed for simultaneous kidney pancreas transplantation
Who may be able to join
- Participant is willing and able to give informed consent
- Diagnosed with type 1 diabetes mellitus with estimated glomerular filtration rate (eGFR)<20ml/min or on renal replacement therapy referred for simultaneous pancreas-kidney (SPK) transplant
Who cannot join
- Participant unable to undergo CPET testing due to limitation on mobility or limb movement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Cardiopulmonary Exercise Capacity in Patients with Type 1 Diabetes Mellitus Approaching Simultaneous Kidney Pancreas Transplantation
Patients being assessed for Kidney Pancreas transplantation often have pre-existing co-morbid disease that contributes to structural cardiac and vascular disease. There is no consensus on optimal pre-listing cardiac assessment to reliably minimize risk of peri-operative cardiac events. Functional status using the cardio-pulmonary exercise test (CPET) has been used in cardiac and abdominal surgery, including abdominal aortic aneurysm (AAA) repair and kidney transplantation, but high risk patients with diabetes are often lacking from these studies. This study will investigate the correlation between function, measures using CPET and standard cardiac assessment, and determine the variation in usual measures of anaerobic threshold and VO2 max in this population.
Read the detailed description
20 participants will be recruited to a blinded observational study. Patients referred for pancreas kidney transplantation assessment will be provided information about the study. They will subsequently be approached at their initial assessment visit and informed consent will be taken.
Participants will have standard clinical assessment which includes:
- Clinical history and examination
- 12 lead electrocardiogram (ECG)
- Chest X-ray (CXR)
- Myocardial perfusion imaging (MPS)
- If MPS imaging is suggestive of stress induced ischaemia, or severe left ventricular (LV) dysfunction, the participant will undergo coronary angiography as part of standard assessment protocol.
In addition, study participants will undergo CPET testing. This will take place within 1 week of the standard peri-operative cardiac assessment. The results of this investigation will be recorded against a unique identifier on a secure Oxford University Hospital computer. Information about the study or participants' individual results will not normally be disclosed to the participant or clinical team, and so will not influence clinical management. However if, when the results are analysed, the research team note a CPET result that suggests a clear and significant impairment of functional reserve such that the participant should not be listed, this result will be disclosed to the individual and their medical team so that the information can be used in order to make the safest decision about transplant listing. There will be no further clinical visits but participants will consent to collection of their clinical data until 3 months post-transplant, or until they are removed from the waiting list.
At the end of the study, the results of CPET testing will be correlated to measures from standard cardiac investigations and to peri-operative cardiac events.
- Being tested
- Cardiopulmonary exercise test (CPET)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise test (CPET)Diagnostic test
The participant will undergo a cardio-pulmonary exercise test (CPET) on a cycle ergometer (Ergoline) connected to a 12-lead electrocardiogram, oxygen saturation monitor and continuous non-invasive blood pressure cuff. Respiratory gas exchanged will be measured from a tight fitting facemask. An initial 2-min period of baseline data will be collected at rest before a 180-s period of unloaded cycling. A ramp protocol will then be applied and the participant will be instructed to continue cycling at a constant cadence of 60 rpm as long as they can. The test will be terminated if the participant indicates that:
- they cannot continue
- cadence falls to <55 rpm due to fatigue or dyspnoea
- they develop abnormal cardiac signs or symptoms, such as ischaemia and arrhythmia.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Single arm observational study Receives: Diagnostic Test: Cardiopulmonary exercise test (CPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaerobic threshold (AT) measurement correlation with cardiac perfusion
Comparison of AT measurement and MPS imaging result
Measured: Single 1 day test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Mar 2018
- Primary completion14 Sep 2024
- Study completion14 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Sharples, Oxford University Hospitals NHS Trust
- Investigators
- Edward Sharples, MBBS PhD, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312802
- Sponsor's protocol ID
- 251119v1.1
- Status last verified
- Jan 2025
- First submitted
- 16 Mar 2020
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Cardiopulmonary Exercise Capacity in Patients with Type 1 Diabetes Mellitus Approaching Simultaneous Kidney Pancreas Transplantation
- ClinicalTrials.gov ID
- NCT04312802
- Acronym / sponsor ID
- 251119v1.1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 14 Sep 2024 (actual)
- Study completion
- 14 Sep 2024 (actual)
- First posted
- 18 Mar 2020 (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.
Patients being assessed for Kidney Pancreas transplantation often have pre-existing co-morbid disease that contributes to structural cardiac and vascular disease. There is no consensus on optimal pre-listing cardiac assessment to reliably minimize risk of peri-operative cardiac events. Functional status using the cardio-pulmonary exercise test (CPET) has been used in cardiac and abdominal surgery, including abdominal aortic aneurysm (AAA) repair and kidney transplantation, but high risk patients with diabetes are often lacking from these studies. This study will investigate the correlation between function, measures using CPET and standard cardiac assessment, and determine the variation in usual measures of anaerobic threshold and VO2 max in this population.
Detailed description
20 participants will be recruited to a blinded observational study. Patients referred for pancreas kidney transplantation assessment will be provided information about the study. They will subsequently be approached at their initial assessment visit and informed consent will be taken.
Participants will have standard clinical assessment which includes:
- Clinical history and examination
- 12 lead electrocardiogram (ECG)
- Chest X-ray (CXR)
- Myocardial perfusion imaging (MPS)
- If MPS imaging is suggestive of stress induced ischaemia, or severe left ventricular (LV) dysfunction, the participant will undergo coronary angiography as part of standard assessment protocol.
In addition, study participants will undergo CPET testing. This will take place within 1 week of the standard peri-operative cardiac assessment. The results of this investigation will be recorded against a unique identifier on a secure Oxford University Hospital computer. Information about the study or participants' individual results will not normally be disclosed to the participant or clinical team, and so will not influence clinical management. However if, when the results are analysed, the research team note a CPET result that suggests a clear and significant impairment of functional reserve such that the participant should not be listed, this result will be disclosed to the individual and their medical team so that the information can be used in order to make the safest decision about transplant listing. There will be no further clinical visits but participants will consent to collection of their clinical data until 3 months post-transplant, or until they are removed from the waiting list.
At the end of the study, the results of CPET testing will be correlated to measures from standard cardiac investigations and to peri-operative cardiac events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Diagnostic Test: Cardiopulmonary exercise test (CPET)Single arm observational study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with type 1 diabetes mellitus and impaired kidney function being assessed for simultaneous kidney pancreas transplantation
Key inclusion criteria (2 listed)
- Participant is willing and able to give informed consent
- Diagnosed with type 1 diabetes mellitus with estimated glomerular filtration rate (eGFR)<20ml/min or on renal replacement therapy referred for simultaneous pancreas-kidney (SPK) transplant
Key exclusion criteria (1 listed)
- Participant unable to undergo CPET testing due to limitation on mobility or limb movement
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 test (CPET)The participant will undergo a cardio-pulmonary exercise test (CPET) on a cycle ergometer (Ergoline) connected to a 12-lead electrocardiogram, oxygen saturation monitor and continuous non-invasive blood pressure cuff. Respiratory gas exchanged will be measured from a tight fitting facemask. An initial 2-min period of baseline data will be collected at rest before a 180-s period of unloaded cycling. A ramp protocol will then be applied and the participant will be instructed to continue cycling at a constant cadence of 60 rpm as long as they can. The test will be terminated if the participant indicates that: * they cannot continue * cadence falls to <55 rpm due to fatigue or dyspnoea * they develop abnormal cardiac signs or symptoms, such as ischaemia and arrhythmia. | Diagnostic test | Observational |
Primary outcome
Anaerobic threshold (AT) measurement correlation with cardiac perfusion
Time frame: Single 1 day test
Comparison of AT measurement and MPS imaging result
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 22 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Edward Sharples, MBBS PhD principal investigator
Oxford University Hospitals NHS Trust
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 Cardiovascular Risk Factor and Diabetes Mellitus, Type 1, run by Oxford University Hospitals NHS 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 2 inclusion and 1 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 22 Jan 2025. 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?
Anaerobic threshold (AT) measurement correlation with cardiac perfusion (time frame: Single 1 day test). 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 22 Jan 2025.