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Cardiopulmonary Testing for Potential Pancreas Transplant Candidates

NCT04312802 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2025-01-22

No results posted yet for this study

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Oxford University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Edward Sharples, MBBS PhD · Oxford University Hospitals NHS Trust

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2024-09-14
Completion
2024-09-14

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04312802 on ClinicalTrials.gov