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
  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 Blind (Subject, 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698398

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

No publications provided

ClinicalTrials.gov Identifier: NCT01698398     History of Changes
Other Study ID Numbers: H-1-2012-092
Study First Received: October 2, 2012
Last Updated: February 10, 2014
Health Authority: Denmark: Ethics Commitee.

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014