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
Not Applicable
Completed
- Conditions
- Heart Failure.
- Interventions
- Device: Incremental pump speed of CF-LVAD.
- Registration Number
- NCT01698398
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CF-LVAD pumpspeed. Incremental pump speed of CF-LVAD. Optimal pumpspeed setting of CF-LVAD during exercise on ergometric bicycle.
- Primary Outcome Measures
Name Time Method Peak oxygen consumption. Day 1 ml oxygen/minute/kg
- Secondary Outcome Measures
Name Time Method Working capacity. Day 1 Watt
Trial Locations
- Locations (1)
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet.
🇩🇰Copenhagen., Denmark