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Clinical Trials/NCT02335684
NCT02335684
Completed
Not Applicable

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

Rigshospitalet, Denmark1 site in 1 country31 target enrollmentNovember 2013
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Rigshospitalet, Denmark
Enrollment
31
Locations
1
Primary Endpoint
Exercise time
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
October 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Finn Gustafsson

MD

Rigshospitalet, Denmark

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Perceived exertion(Perceived exertion will be estimated during exercise on the ergometer bike on the day of the study.)

Study Sites (1)

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