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Completed

NCT Number: NCT02335684

Effects of Increased CF-LVAD Pump Speed During Sustained Submaximal Exercise

This randomized trial has been designed to study if it is possible to enhance work capacity during submaximal efforts in heart failure patients supported with continuous-flow left ventricular assist devices (CF-LVAD).

The hypothesis is that exercise tolerability during low to moderate workloads in CF-LVAD patients can be increased when pump speed is increased soon after the onset of exercise.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Copenhagen; Rigshospitalet.

Copenhagen Oe, 2100, Denmark

About this study

To test the hypothesis described above the investigators will study submaximal exercise tests below anaerobic threshold in patients supported with CF-LVADs.Each patient will perform two tests- one with baseline CF-LVAD pump speed and the other with incrementally increased pump speed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ischemic and non-ischemic cardiomyopathy patients with CF-LVADs,signed informed consent.

Exclusion criteria

  • Unstable patients, CF-LVAD implantation less than three months ago.

Treatment and study plan

CF-LVAD pump speed baseline.

Other

Submaximal exercise test with baseline pump speed.

CF-LVAD pump speed increased.

Other

Submaximal exercise test with increased pump speed (+800RPM).

Primary outcomes

  1. Exercise time

    Time frame: Exercise time will be estimated only on the day of the study. No follow-up.

    Exercise will be performed on a upright ergometer bike with simultaneously breath-by-breath gaz analysis.

Secondary outcomes

  1. Perceived exertion

    Time frame: Perceived exertion will be estimated during exercise on the ergometer bike on the day of the study.

    Rate of exertion will be estimated using the Borg Scale.

Other outcomes

  1. Heart rate

    Time frame: Heart rate will be measures during exercise.

    Heart rate is measured by ECG monitoring.

  2. Anaerobic threshold

    Time frame: Anaerobic threshold is measured during exercise on the study day.

    Anaerobic threshold is defined as respiratory exchange rate (RER) >1.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Danish Heart Foundation

Registry information

Official study title

Improving Functional Capacity in Heart Failure Patients Supported With Continuous-flow Left Ventricular Assist Devices. -Effects of Increased Pump Speed During Sustained Submaximal Exercise

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 12, 2015
Registry last updated
Oct 28, 2015

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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