Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Devices

Study Overview
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Brief Summary
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Investigation of oxygen uptake during daily life activities in HF patients with and without LVADs.

Detailed Description
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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.

Official Title
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Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Device

Conditions
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Left Ventricular Failure, Unspecified

Intervention / Treatment
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* Other: Measurement of peak oxygen uptake


Participation Criteria
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Eligibility Criteria
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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)

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized crossover study: Peak oxygen uptake vs VO2 measure during specific daily life activities in LVAD recipients Peak oxygen uptake vs VO2 measure during specific daily life activities in healthy controls
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LVAD recipients<br>Peak oxygen uptake vs VO2 measure during specific daily life activities in LVAD recipients | Other: Measurement of peak oxygen uptake<br>* Oxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2).<br>|
| Experimental: Healthy controls<br>Peak oxygen uptake vs VO2 measure during specific daily life activities in healthy controls. | Other: Measurement of peak oxygen uptake<br>* Oxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2 | Oxygen uptake | Stable LVAD recipients on average 2 years after the implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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left ventricular assist device, oxygen uptake, daily life activity, quality of life