Cardiopulmonary Testing for Potential Pancreas Transplant Candidates

NCT ID: NCT04312802

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2024-09-14

Brief 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. 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:

1. Clinical history and examination

2. 12 lead electrocardiogram (ECG)

3. Chest X-ray (CXR)

4. Myocardial perfusion imaging (MPS)

5. 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.

Conditions

Cardiovascular Risk Factor; Diabetes Mellitus, Type 1; Pancreas Transplant; Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observational

Single arm observational study

Cardiopulmonary exercise test (CPET)

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Participant unable to undergo CPET testing due to limitation on mobility or limb movement

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Edward Sharples

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward Sharples, MBBS PhD

Role: PRINCIPAL_INVESTIGATOR

Oxford University Hospitals NHS Trust

Locations

Churchill Hospital

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

251119v1.1

Identifier Type: -

Identifier Source: org_study_id