Heart Failure
Conditions
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.
Interventions
Sponsors
Finn Gustafsson
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Oxygen Uptake | Day 1 | Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Right Ventricular Function (RVEF) During Exercise | Day 1 | Right ventricular function during exercise was estimated by use of contrast enhanced cardiac computed tomography. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 Arm Study: CCT Estimated Right Ventricular Function. Cardiac Computed tomography | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | 1 Arm Study: CCT Estimated Right Ventricular Function. |
|---|---|
| Age, Customized Age | 60 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Peak Oxygen Uptake
Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-arm Study: Exercise and Right Ventricular Function in Patients With LVADs | Peak Oxygen Uptake | 15 ml/kg/min | Standard Deviation 5 |
Secondary
Right Ventricular Function (RVEF) During Exercise
Right ventricular function during exercise was estimated by use of contrast enhanced cardiac computed tomography.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-arm Study: Exercise and Right Ventricular Function in Patients With LVADs | Right Ventricular Function (RVEF) During Exercise | 37 percent of ejected blood | Standard Deviation 8 |