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

Primary Purpose

Cardiovascular Diseases+Liver Transplantation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiopulmonary exercise testing
Sponsored by
Andres Duarte-Rojo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiovascular Diseases+Liver Transplantation

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPET

Arm Description

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

Outcomes

Primary Outcome Measures

Cardiopulmonary exercise testing and cardiac stress testing
Agreement between cardiopulmonary exercise testing and cardiac stress testing (SOC), for the identification of subclinical coronary artery disease in liver transplant candidates
Cardiopulmonary exercise testing and dobutamine stress echocardiogram
Agreement between cardiopulmonary exercise testing and dobutamine stress echocardiogram (SOC) to identify cirrhotic cardiomyopathy in liver transplant candidates
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 to identify frailty in liver transplant candidates

Secondary Outcome Measures

Full Information

First Posted
September 2, 2020
Last Updated
July 7, 2022
Sponsor
Andres Duarte-Rojo
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1. Study Identification

Unique Protocol Identification Number
NCT04543825
Brief Title
Usefulness of Cardiopulmonary Exercise Testing for Cardiovascular Risk Estimation and Frailty Assessment in Liver Transplant Candidates
Official Title
Usefulness of Cardiopulmonary Exercise Testing for Cardiovascular Risk Estimation and Frailty Assessment in Liver Transplant Candidates
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andres Duarte-Rojo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases+Liver Transplantation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPET
Arm Type
Experimental
Arm Description
Patients with cirrhosis who have been wait listed for liver transplant or are undergoing liver transplant evaluation and will undergo cardiopulmonary exercise testing (CPET).
Intervention Type
Device
Intervention Name(s)
Cardiopulmonary exercise testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiopulmonary exercise testing and cardiac stress testing
Description
Agreement between cardiopulmonary exercise testing and cardiac stress testing (SOC), for the identification of subclinical coronary artery disease in liver transplant candidates
Time Frame
12 months
Title
Cardiopulmonary exercise testing and dobutamine stress echocardiogram
Description
Agreement between cardiopulmonary exercise testing and dobutamine stress echocardiogram (SOC) to identify cirrhotic cardiomyopathy in liver transplant candidates
Time Frame
12 months
Title
Peak oxygen consumption from cardiopulmonary exercise testing
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Duarte-Rojo, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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

Learn more about this trial

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

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