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

NCT04543825 | Completed FDA Device

• 1 other identifier: STUDY19100373
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Diseases+Liver Transplantation

Keywords

6-minute walk test, cirrhosis, frailty, major adverse cardiac event

Outcome Measures

Primary Outcomes (3)

• Cardiopulmonary exercise testing and cardiac stress testing

  Agreement between cardiopulmonary exercise testing and cardiac stress testing, for the identification of subclinical coronary artery disease in liver transplant candidates.

  12 months

• Cardiopulmonary exercise testing and dobutamine stress echocardiogram

  Agreement between cardiopulmonary exercise testing and dobutamine stress echocardiogram (DSE) or impedance cardiography, for the identification of cirrhotic cardiomyopathy in liver transplant candidates.

  12 months

• Peak oxygen consumption from cardiopulmonary exercise testing

  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.

  12 months

Study Arms (1)

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).

Device: Cardiopulmonary exercise testing

Interventions

Cardiopulmonary exercise testing 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).

CPET

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients waitlisted for a liver transplant or undergoing liver transplant evaluation

You may qualify if:

• Wait listed patients with cirrhosis or those undergoing LT evaluation

You may not qualify if:

• 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

Sponsors & Collaborators

• Andres Duarte-Rojo: lead

Study Sites (2)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Fibrosis; Frailty

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Andres Duarte-Rojo, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 10, 2020
• Study Start: September 25, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)