NCT04543825

Usefulness of Cardiopulmonary Exercise Testing for Cardiovascular Risk Estimation and Frailty Assessment in Liver Transplant Candidates

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 54 (actual)
• Sponsor: Andres Duarte-Rojo · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients undergoing liver transplantation (LT) have a high risk for cardiovascular disease (CVD). Frailty is a frequent condition among LT candidates. Together, CVD and frailty are major causes of morbidity and mortality before and after LT. Conventional methods to diagnose and predict CVD in LT candidates lack sensitivity and clinically relevant application. However, cardiopulmonary exercise testing (CPET) can directly estimate coronary artery disease, cirrhotic cardiomyopathy, and indirectly assess frailty. Such versatility of CPET has caused it to become the standard of care in many LT centers outside of the United States. In preliminary work (funded internally by the Pittsburgh Liver Research Center) that will be used to fund a more definitive study (RO1), the investigators plan to investigate CVD and frailty in LT candidates, both from existing standard of care (SOC) methods and CPET. The investigators expect results to improve the current capacity to assess and prognosticate CVD and frailty in LT, ultimately changing practice.

Detailed description

Patients undergoing liver transplantation (LT) have a high risk for cardiovascular disease (CVD). Frailty is a frequent condition among LT candidates. Together, CVD and frailty are major causes of morbidity and mortality before and after LT. Conventional methods to diagnose and predict CVD in LT candidates lack sensitivity and clinically relevant application. However, cardiopulmonary exercise testing (CPET) can directly estimate coronary artery disease, cirrhotic cardiomyopathy, and indirectly assess frailty. Such versatility of CPET has caused it to become the standard of care in many LT centers outside of the United States. In preliminary work that will be used to fund a more definitive study (RO1), the investigators plan to investigate CVD and frailty in LT candidates, both from existing standard of care (SOC) methods and CPET. The investigators expect results to improve the assessment of CVD and frailty in LT, ultimately changing practice. The investigators' proposal will pursue the following Specific Aims (SA): Aim 1: Prospectively determine agreement between cardiopulmonary exercise testing and cardiac stress testing, for the identification of subclinical coronary artery disease in liver transplant candidates. Aim 2: Prospectively determine agreement between cardiopulmonary exercise testing and dobutamine stress echocardiogram (DSE) or impedance cardiography, for the identification of cirrhotic cardiomyopathy in liver transplant candidates. Aim 3: Prospectively determine agreement between peak oxygen consumption from cardiopulmonary exercise testing and the liver frailty index or the six-minute walk test, for the identification of frailty in liver transplant candidates.

Conditions

• Cardiovascular Diseases+Liver Transplantation

Interventions

Type	Name	Description
DEVICE	Cardiopulmonary exercise testing	Subjects will perform cardiopulmonary exercise testing which consists of biking on a cycle ergometer (recumbant stationary bicycle) while breathing through a mouthpiece or mask to measure the oxygen and carbon dioxide in the subject's breath. We will also do impedance cardiography, an FDA-approved test to check how the heart functions during exercise. For this test we will attach 6 electrodes (total) to the chest and back (similar to an EKG), so that we can measure the quantity of blood coming out of the heart on every heartbeat. Each evaluation will also include cardiac testing looking for coronary artery disease (CAD).

Timeline

• Start date: 2020-09-25
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2020-09-10
• Last updated: 2024-04-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study