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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01698398
First Posted: October 3, 2012
Last Update Posted: February 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  Purpose

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 Intervention
Heart Failure. Device: Incremental pump speed of CF-LVAD.

Study Type: Interventional
Study Design: Allocation: Randomized
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.

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Peak oxygen consumption. [ Time Frame: Day 1 ]
    ml oxygen/minute/kg


Secondary Outcome Measures:
  • Working capacity. [ Time Frame: Day 1 ]
    Watt


Other Outcome Measures:
  • 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)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Denmark
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet.
Copenhagen., Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01698398     History of Changes
Other Study ID Numbers: H-1-2012-092
First Submitted: October 2, 2012
First Posted: October 3, 2012
Last Update Posted: February 11, 2014
Last Verified: October 2012

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases