Clinical trial NCT04732039: Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Devices
Official title: Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Left Ventricular Failure, Unspecified
Keywords: left ventricular assist device
oxygen uptake
daily life activity
quality of life
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: OTHER

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.

Eligibility 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)

Primary outcomes:
measure: VO2
timeFrame: Stable LVAD recipients on average 2 years after the implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: DK
Study officials:
affiliation: Rigshospitalet, Denmark
name: Finn Gustafsson, MD,PhD,DMSci
role: PRINCIPAL_INVESTIGATOR
References: