The Increase Study. Effect of Incremental Versus Fixed Pump on Peak Oxygen Consumption in Heart Failure Patients Supported With a Continuous Flow Left Venticular Assist Device
The purpose of the study is to examine the relationship between working capacity (peak oxygen consumption) and pump speed of continuous flow left ventricular assist devices (CF-LVADs)in heart failure patients. The hypothesis is that it is possible to increase peak oxygen consumption by incrementally increasing CF-LVAD pumpspeed during exercise.
The study population will consist of severe heart failure patients with CF-LVADs treated at The Heart Centre of Copenhagen University Hospital Rigshospitalet.
|Study Design:||Allocation: Randomized
Masking: Double Blind (Subject, Investigator)
|Official Title:||The Increase Study. Effect of Incremental Versus Fixed Pump on Peak Oxygen Consumption in Heart Failure Patients Supported With a Continuous Flow Left Venticular Assist Device.|
- Peak oxygen consumption. [ Time Frame: Day 1 ]ml oxygen/minute/kg
- Working capacity. [ Time Frame: Day 1 ]Watt
- Exercise time (minutes), anerobic threshold. [ Time Frame: Day 1 ]
|Study Start Date:||October 2012|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: CF-LVAD pumpspeed.
Optimal pumpspeed setting of CF-LVAD during exercise on ergometric bicycle.
Device: Incremental pump speed of CF-LVAD.
Peak oxygen consumption with fixed versus incremental pump speed.
Other Name: HeartMate II.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698398
|Department of Cardiology, Copenhagen University Hospital, Rigshospitalet.|
|Copenhagen., Denmark, 2100|