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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: CF-LVAD pump speed baseline.; Other: CF-LVAD pump speed increased.

• Registration Number: NCT02335684
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-12
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CF-LVAD patients.	CF-LVAD pump speed increased.	Patients are compared with themselves during submaximal exercise testing with baseline pump speed vs. submaximal exercise testing with increased pump speed.
CF-LVAD patients.	CF-LVAD pump speed baseline.	Patients are compared with themselves during submaximal exercise testing with baseline pump speed vs. submaximal exercise testing with increased pump speed.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital of Copenhagen; Rigshospitalet.; 🇩🇰 Copenhagen Oe, Denmark