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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01698398

Enrollment

Unknown

Registered

2012-10-03

Start date

2012-10-31

Completion date

Unknown

Last updated

2014-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure.

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.

Interventions

DEVICEIncremental pump speed of CF-LVAD.

Peak oxygen consumption with fixed versus incremental pump speed.

Study design

Allocation

RANDOMIZED

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Peak oxygen consumption.	Day 1	ml oxygen/minute/kg

Secondary

Measure	Time frame	Description
Working capacity.	Day 1	Watt

Other

Measure	Time frame
Exercise time (minutes), anerobic threshold.	Day 1

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026