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
|ClinicalTrials.gov Identifier: NCT01698398|
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : February 11, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure.||Device: Incremental pump speed of CF-LVAD.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Masking:||Double (Participant, 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.|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||January 2013|
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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698398
|Department of Cardiology, Copenhagen University Hospital, Rigshospitalet.|
|Copenhagen., Denmark, 2100|