Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Devices
NCT ID: NCT04732039
Last Updated: 2021-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-02-08
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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
OTHER
NONE
Study Groups
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LVAD recipients
Peak oxygen uptake vs VO2 measure during specific daily life activities in LVAD recipients
Measurement of peak oxygen uptake
Oxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2).
Healthy controls
Peak oxygen uptake vs VO2 measure during specific daily life activities in healthy controls.
Measurement of peak oxygen uptake
Oxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2).
Interventions
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Measurement of peak oxygen uptake
Oxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2).
Eligibility Criteria
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Inclusion Criteria
* Age\>18yrs
* Signed informed consent
Exclusion Criteria
* Not able to complete VO2 test (physicians decision)
18 Years
100 Years
ALL
Yes
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Finn Gustafsson
Professor
Principal Investigators
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Finn Gustafsson, MD,PhD,DMSci
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, DK, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-20049568
Identifier Type: -
Identifier Source: org_study_id
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