Left Ventricular Failure, Unspecified
Conditions
Keywords
left ventricular assist device, oxygen uptake, daily life activity, quality of life
Brief summary
Investigation of oxygen uptake during daily life activities in HF patients with and without LVADs.
Detailed description
In patients with terminal HF the gold standard for treatment is heart transplantation, though the Worldwide shortage of donor organs has led to increased use of implantable mechanical circulatory support devices. The treatment with implantable pumps in the form of a Continuous Flow Left Ventricular Assist Device (CF-LVAD, or simply LVAD) is extremely effective for a selected patient groups leading to significant improvement in survival and quality of life. The device is a battery-powered flow pump that carries the blood from the left ventricle to the main artery, via a cannula, and thus relieves the failing left ventricle with up to 10 liters of blood per minute. An LVAD can be used both as lifelong support therapy (Destination Therapy, DT) or until transplantation can take place (Bridge therapy). As patients today live for more than 10 years with the device as DT, the focus has shifted from mere survival to quality of life and physical ability. In recent years, our research group showed that the pump speed and the patient's baseline heart rhythm (sinus rhythm vs atrial fibrillation) and reduced ability to regulate the intrinsic rhythm after implantation (chronotropic incompetence) are significant contributors to the reduced exercise capacity seen in this patient group. Until now, studies have elucidated the work capacity of this patient group using a 6-minute walk test or bicycle test - none of these reflect how well the patient actually functions in his everyday life. In this study, we will describe oxygen uptake related to specific daily activities (ADL-VO2) and compare these with the well-known maximum work capacity (percentage of expected oxygen uptake / pVO2) in this patient group.
Interventions
OTHERMeasurement of peak oxygen uptake
Oxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2).
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized crossover study: 1. Peak oxygen uptake vs VO2 measure during specific daily life activities in LVAD recipients 2. Peak oxygen uptake vs VO2 measure during specific daily life activities in healthy controls
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
LVADs: Inclusion Criteria: * Implanted durable left ventricular assist device * Age\>18yrs * Signed informed consent
Exclusion criteria
* No consent * Not able to complete VO2 test (physicians decision)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2 | Stable LVAD recipients on average 2 years after the implantation | Oxygen uptake |
Countries
Denmark
Contacts
Primary ContactKiran K Mirza, MD
Backup ContactFinn Gustafsson, MD, PhD, DMSci
Outcome results
None listed