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
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698398
|Department of Cardiology, Copenhagen University Hospital, Rigshospitalet.|
|Copenhagen., Denmark, 2100|