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

NCT ID: NCT04543825

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-25
• Study Completion Date: 2022-05-31

Brief 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

Study Design

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

Study Groups

CPET

Patients with cirrhosis who have been wait listed for liver transplant or are undergoing liver transplant evaluation and will undergo cardiopulmonary exercise testing (CPET).

Cardiopulmonary exercise testing

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Wait listed patients with cirrhosis or those undergoing LT evaluation

Exclusion Criteria

• Subjects younger than 45 or older than 75 years
• Subjects with platelets <30,000
• Subjects with international normalized range (INR) >3
• Subjects with glomerular filtration rate (GFR) <30
• Subjects with left main artery stenosis
• Subjects with moderate/severe stenotic valvular disease
• Subjects with atrial fibrillation and other arrythmias
• Subjects with resting ventricular ejection fraction <50%
• Subjects with portopulmonary hypertension
• Subjects with severe chronic obstructive pulmonary disease (COPD)
• Subjects with an exercise contraindication

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andres Duarte-Rojo

OTHER

Sponsor Role: lead

Responsible Party

Andres Duarte-Rojo

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andres Duarte-Rojo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Mayo Clinic Arizona

Phoenix, Arizona, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY19100373

Identifier Type: -

Identifier Source: org_study_id