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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 is currently recruiting participants.
Verified October 2012 by Rigshospitalet, Denmark
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01698398
First received: October 2, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  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:

U.S. FDA Resources

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
Estimated Primary Completion Date: October 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698398

Contacts
Contact: Finn Gustafsson, MD, DMSc 004535459743 finng@dadlnet.dk
Contact: Mette Jung, MD 004535452142 metteholmejung@dadlnet.dk

Locations
Denmark
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet. Recruiting
Copenhagen., Denmark, 2100
Contact: Finn Gustafsson, MD, DMSc         finng@dadlnet.dk    
Principal Investigator: Finn Gustafsson, MD, DMSc            
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: October 2, 2012
Health Authority: Denmark: Ethics Commitee.

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013