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

Rigshospitalet, Denmark

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Conditions

Heart Failure.

Interventions

Incremental pump speed of CF-LVAD.DEVICE

Peak oxygen consumption with fixed versus incremental pump speed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Cardiology, Copenhagen University Hospital, Rigshospitalet.

Copenhagen, Denmark

Outcomes

Primary Outcomes

Peak oxygen consumption.

ml oxygen/minute/kg

Time frame: Day 1

Secondary Outcomes

Working capacity.

Watt

Time frame: Day 1

Data from ClinicalTrials.gov

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