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

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01698398
First received: October 2, 2012
Last updated: February 10, 2014
Last verified: October 2012

October 2, 2012
February 10, 2014
October 2012
January 2013   (final data collection date for primary outcome measure)
Peak oxygen consumption. [ Time Frame: Day 1 ]
ml oxygen/minute/kg
Same as current
Complete list of historical versions of study NCT01698398 on ClinicalTrials.gov Archive Site
Working capacity. [ Time Frame: Day 1 ]
Watt
Same as current
Exercise time (minutes), anerobic threshold. [ Time Frame: Day 1 ]
Same as current
 
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 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Masking: Double Blind (Subject, Investigator)
Heart Failure.
Device: Incremental pump speed of CF-LVAD.
Peak oxygen consumption with fixed versus incremental pump speed.
Other Name: HeartMate II.
Experimental: CF-LVAD pumpspeed.
Optimal pumpspeed setting of CF-LVAD during exercise on ergometric bicycle.
Intervention: Device: Incremental pump speed of CF-LVAD.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HeartMate II patients who underwent surgery and follow-up at The Heart Centre of Rigshospitalet.
  • Heart failure in stable phase without the need for intravenous inotropic therapy.
  • Ischemic and non-ischemic cardiomyopathy.

Exclusion Criteria:

  • Severe aortic insufficiency.
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01698398
H-1-2012-092
Not Provided
Not Provided
Rigshospitalet, Denmark
Not Provided
Not Provided
Rigshospitalet, Denmark
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP