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

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ClinicalTrials.gov Identifier: NCT04543825
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : December 13, 2021
Sponsor:
Information provided by (Responsible Party):
Andres Duarte-Rojo, University of Pittsburgh

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases+Liver Transplantation Device: Cardiopulmonary exercise testing Not Applicable

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 (SOC), 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 (SOC), 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 (SOC), for the identification of frailty in liver transplant candidates.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Usefulness of Cardiopulmonary Exercise Testing for Cardiovascular Risk Estimation and Frailty Assessment in Liver Transplant Candidates
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Cardiopulmonary exercise testing and cardiac stress testing [ Time Frame: 12 months ]
    Agreement between cardiopulmonary exercise testing and cardiac stress testing (SOC), for the identification of subclinical coronary artery disease in liver transplant candidates

  2. Cardiopulmonary exercise testing and dobutamine stress echocardiogram [ Time Frame: 12 months ]
    Agreement between cardiopulmonary exercise testing and dobutamine stress echocardiogram (SOC) to identify cirrhotic cardiomyopathy in liver transplant candidates

  3. Peak oxygen consumption from cardiopulmonary exercise testing [ Time Frame: 12 months ]
    Agreement between peak oxygen consumption from cardiopulmonary exercise testing and the liver frailty index or the six-minute walk test to identify frailty in liver transplant candidates


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Wait listed patients with cirrhosis or those undergoing LT evaluation

Exclusion Criteria:

  • Subjects younger than 50 or older than 70 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543825


Contacts
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Contact: Andres Duarte-Rojo, MD 412-647-1170 duarterojoa@pitt.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Andres Duarte-Rojo, MD         
Sponsors and Collaborators
Andres Duarte-Rojo
Investigators
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Principal Investigator: Andres Duarte-Rojo, MD University of Pittsburgh
More Information
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Responsible Party: Andres Duarte-Rojo, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04543825    
Other Study ID Numbers: STUDY19100373
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: December 13, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators will construct a REDCap database to collect deidentified research data, as per IRB-approved clinical research form, for a combined analysis of all recruiting centers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Cardiovascular Diseases
Frailty
Pathologic Processes