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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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT01698398
Collaborator
(none)
1
Location
1
Arm

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Incremental pump speed of CF-LVAD.
 N/A

Study Design

Study Type:
Interventional
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.
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • HeartMate II.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Peak oxygen consumption. [Day 1]

      ml oxygen/minute/kg

    Secondary Outcome Measures

    1. Working capacity. [Day 1]

      Watt

    Other Outcome Measures

    1. Exercise time (minutes), anerobic threshold. [Day 1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Department of Cardiology, Copenhagen University Hospital, Rigshospitalet. Copenhagen. Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01698398
    Other Study ID Numbers:
    • H-1-2012-092
    First Posted:
    Oct 3, 2012
    Last Update Posted:
    Feb 11, 2014
    Last Verified:
    Oct 1, 2012
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Feb 11, 2014