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OpenTrials
Completed

NCT Number: NCT01698398

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 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.

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Key information

Conditions

Heart Failure. Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Copenhagen University Hospital, Rigshospitalet.

Copenhagen, 2100, Denmark

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Incremental pump speed of CF-LVAD.

Device

Peak oxygen consumption with fixed versus incremental pump speed.

Other names: HeartMate II.

Primary outcomes

  1. Peak oxygen consumption.

    Time frame: Day 1

    ml oxygen/minute/kg

Secondary outcomes

  1. Working capacity.

    Time frame: Day 1

    Watt

Other outcomes

  1. Exercise time (minutes), anerobic threshold.

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
First posted
Oct 3, 2012
Registry last updated
Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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