Back to resultsRight Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cardiac Computed tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure
Eligibility Criteria
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.
Sites / Locations
- University Hospital Rigshospitalet.
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1 arm study: CCT estimated right ventricular function.
Arm Description
By use of Cardiac computed tomography, the ejection faction of the right ventricle will be visualized and measured in all participants.
Outcomes
Primary Outcome Measures
Peak Oxygen Uptake
Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min.
Secondary Outcome Measures
Right Ventricular Function (RVEF) During Exercise
Right ventricular function during exercise was estimated by use of contrast enhanced cardiac computed tomography.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02658136
Brief Title
Right Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices
Official Title
Computed Tomography Estimated Right Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
August 15, 2017 (Actual)
Study Completion Date
August 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Finn Gustafsson
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 arm study: CCT estimated right ventricular function.
Arm Type
Other
Arm Description
By use of Cardiac computed tomography, the ejection faction of the right ventricle will be visualized and measured in all participants.
Intervention Type
Other
Intervention Name(s)
Cardiac Computed tomography
Primary Outcome Measure Information:
Title
Peak Oxygen Uptake
Description
Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Right Ventricular Function (RVEF) During Exercise
Description
Right ventricular function during exercise was estimated by use of contrast enhanced cardiac computed tomography.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University Hospital Rigshospitalet.
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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Right Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices
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