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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02335684

Enrollment

Registered

2015-01-12

Start date

2013-11-30

Completion date

2015-10-31

Last updated

2015-10-28

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

Conditions

Heart Failure

Keywords

Heart-assist devices, exercise capacity

Brief summary

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.

Detailed description

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.

Interventions

OTHERCF-LVAD pump speed baseline.

Submaximal exercise test with baseline pump speed.

OTHERCF-LVAD pump speed increased.

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Exercise time	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

Measure	Time frame	Description
Perceived exertion	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

Measure	Time frame	Description
Heart rate	Heart rate will be measures during exercise.	Heart rate is measured by ECG monitoring.
Anaerobic threshold	Anaerobic threshold is measured during exercise on the study day.	Anaerobic threshold is defined as respiratory exchange rate (RER) \>1.

Countries

Denmark

Outcome results

None listed

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