Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04732039 |
| Other study ID # |
H-20049568 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 8, 2021 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
February 2021 |
| Source |
Rigshospitalet, Denmark |
| Contact |
Kiran K Mirza, MD |
| Phone |
+4535451442 |
| Email |
KMIR0003[@]regionh.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Investigation of oxygen uptake during daily life activities in HF patients with and without
LVADs.
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.
