NCT01698398CompletedNot Applicable
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.
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Locations
- 1
- Primary Endpoint
- Peak oxygen consumption.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
CF-LVAD pumpspeed.
Experimental
Optimal pumpspeed setting of CF-LVAD during exercise on ergometric bicycle.
Intervention: Incremental pump speed of CF-LVAD. (Device)
Outcomes
Primary Outcomes
Peak oxygen consumption.
Time Frame: Day 1
ml oxygen/minute/kg
Secondary Outcomes
- Working capacity.(Day 1)
Investigators
Study Sites (1)
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