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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
Sponsor:
Information provided by:
Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE October 2, 2012
First Posted Date  ICMJE October 3, 2012
Last Update Posted Date February 11, 2014
Study Start Date  ICMJE October 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
Peak oxygen consumption. [ Time Frame: Day 1 ]
ml oxygen/minute/kg
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
Working capacity. [ Time Frame: Day 1 ]
Watt
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 2, 2012)
Exercise time (minutes), anerobic threshold. [ Time Frame: Day 1 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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.
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Masking: Double (Participant, Investigator)
Condition  ICMJE Heart Failure.
Intervention  ICMJE Device: Incremental pump speed of CF-LVAD.
Peak oxygen consumption with fixed versus incremental pump speed.
Other Name: HeartMate II.
Study Arms  ICMJE Experimental: CF-LVAD pumpspeed.
Optimal pumpspeed setting of CF-LVAD during exercise on ergometric bicycle.
Intervention: Device: Incremental pump speed of CF-LVAD.
Publications * Jung MH, Hansen PB, Sander K, Olsen PS, Rossing K, Boesgaard S, Russell SD, Gustafsson F. Effect of increasing pump speed during exercise on peak oxygen uptake in heart failure patients supported with a continuous-flow left ventricular assist device. A double-blind randomized study. Eur J Heart Fail. 2014 Apr;16(4):403-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01698398
Other Study ID Numbers  ICMJE H-1-2012-092
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rigshospitalet, Denmark
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rigshospitalet, Denmark
Verification Date October 2012

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