RecruitingACTRN12624000321549

Cardiovascular Risk in Cirrhotic Cardiomyopathy (CRICC) - Evaluation of Cardiovascular Risk Prediction in Patients Undergoing Liver Transplantation

Cirrhotic Cardiomyopathy and Evaluation of Cardiovascular Risk Prediction in Patients Undergoing Liver Transplantation

Sponsor

National Health and Medical Reasearch Council (NHMRC) - Post graduate scholarship

Enrollment

200 participants

Start Date

Mar 25, 2024

Study Type

Observational

Conditions

Liver Transplantation Cirrhotic Cardiomyopathy

Summary

Liver transplantation offers a cure for Australians with end-stage liver failure. Cardiovascular disease remains a leading cause of death following this procedure, with rates of post-transplant cardiac events remaining high over the past 20 years despite improvements in overall complication rates. This may be due to undetected cardiac dysfunction, termed cirrhotic cardiomyopathy, however our ability to diagnose and treat this condition in clinical practice remains limited. Using a novel, validated method for identifying this condition using stress testing, we aim to evaluate whether cirrhotic cardiomyopathy increases the risk of post-transplant cardiovascular events, and determine whether liver transplantation leads to a reversal of this condition. Based on the outcome of this study, the long-term goal is to assess whether use of early treatments in patients with cirrhotic cardiomyopathy can reduce the risk of post-transplant cardiovascular events and improve patient outcomes.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Liver transplantation can be a life-saving treatment for people with severe liver failure, but cardiovascular complications — heart attacks, heart failure — remain one of the leading causes of death after transplant. One possible reason is a condition called 'cirrhotic cardiomyopathy', where the heart becomes weakened by the effects of liver disease, often without obvious symptoms beforehand. This study at Austin Health is using a stress test called dobutamine stress echocardiography — which uses a drug to temporarily speed up the heart and ultrasound to watch how it responds — to identify patients with this hidden heart condition before their transplant. Researchers will then follow patients after transplant to see if those with cirrhotic cardiomyopathy do have worse cardiac outcomes, and whether the transplant itself can reverse the heart condition. You may be eligible if you are an adult (18+) on the liver transplant waitlist at Austin Health (Victoria/Tasmania) and are scheduled for the standard pre-operative cardiac assessment. People with overt heart failure, severe valve disease, or significant retinal conditions preventing proper eye examination are not eligible. Identifying this hidden risk factor could eventually allow for early treatment that saves lives after transplant.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

There are no medical interventions in this trial, just additional medical tests. Patients will undergo a follow up dobutamine stress echocardiogram (DSE) (a cardiac stress test that is routinely pe

There are no medical interventions in this trial, just additional medical tests. Patients will undergo a follow up dobutamine stress echocardiogram (DSE) (a cardiac stress test that is routinely performed in the liver transplant workup period) to assess for resolution of the changes that are proposed to be associated with cirrhotic cardiomyopathy. This test takes approximately 30 minutes and will be performed at the Austin Hospital Cardiology department in Heidelberg Victoria. The test will be performed approximately 3 months post liver transplantation. Pathology samples will be taken and stored during both pre-operative and post-operative DSEs during the cannulation that is required for the test. Patients will also undergo a non-invasive assessment of their retinal vasculature using the dynamic vessel analyser camera. This process takes approximately 20-30 minutes and will be performed at the Austin Hospital in Heidelberg Victoria by a trained orthoptist. This will assess the patient's microvascular function which will then be correlated with their post-transplant outcomes. Patients will then have repeat testing approximately 3 months post liver transplantation.