Right Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices

Study Overview
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Brief Summary
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Exercise capacity in continous-flow left ventricular assist device (CF-LVAD) patients remains severely reduced post-implant. While the effect of right ventricular (RV) failure early after pump implantation, and its effect on outcome has been extensively studied, the effects of late RV failure on exercise capacity and quality of life (QOL) has been sparsely described. Thus the purpose of this study is to examine RV function and the association to exercise capacity in CF-LVAD patients.

Detailed Description
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When pharmacological therapy becomes insufficient in advanced end-stage heart failure (HF) transplantation remains the gold standard of therapies. However, due to a severe lack of donor organs, mechanical circulatory support is an alternative option for some eligible patients. Mechanical circulatory support in the form of a CF-LVAD is a pump supporting the left ventricle by pumping blood from the apex to the ascending aortae. Implantation with a CF-LVAD increases survival and improves quality of life, but peak oxygen uptake (peak VO2) remains severely reduced post-implant. Complex central and peripheral hallmarks of heart failure attribute to the continued work intolerance. Furthermore a fixed CF-LVAD pump speed prevents adequate circulatory support during strenuous exercise. The effects of late right ventricular (RV) failure on exercise capacity and quality of life (QOL) is, however, unknown and the purpose of this study is to examine RV function and the association to exercise capacity in CF-LVAD patients.

Official Title
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Computed Tomography Estimated Right Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Cardiac Computed tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients from Department of Cardiology, Rigshospitalet, Denmark. Age ≥ 18 years. Ischemic or non-ischemic cardiomyopathy. Signed informed consent. Exclusion Criteria: Unstable patients with the need for intravenous inotropic therapy. CF-LVAD implantation less than one month ago. eGFR < 45 ml/min. Contrast allergy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1 arm study: CCT estimated right ventricular function.<br>By use of Cardiac computed tomography, the ejection faction of the right ventricle will be visualized and measured in all participants. | Other: Cardiac Computed tomography<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Oxygen Uptake | Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right Ventricular Function (RVEF) During Exercise | Right ventricular function during exercise was estimated by use of contrast enhanced cardiac computed tomography. | Day 1 |