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

Heart Failure Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335684
• Other study ID #: H-1-2013-103
• Status: Completed
• Phase: N/A
• First received: January 20, 2014
• Last updated: October 26, 2015
• Start date: November 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• CF-LVAD pump speed baseline.
Submaximal exercise test with baseline pump speed.
• CF-LVAD pump speed increased.
Submaximal exercise test with increased pump speed (+800RPM).

Locations

Country	Name	City	State
Denmark	University Hospital of Copenhagen; Rigshospitalet.	Copenhagen Oe

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Danish Heart Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate	Heart rate is measured by ECG monitoring.	Heart rate will be measures during exercise.	No
Other	Anaerobic threshold	Anaerobic threshold is defined as respiratory exchange rate (RER) >1.	Anaerobic threshold is measured during exercise on the study day.	No
Primary	Exercise time	Exercise will be performed on a upright ergometer bike with simultaneously breath-by-breath gaz analysis.	Exercise time will be estimated only on the day of the study. No follow-up.	No
Secondary	Perceived exertion	Rate of exertion will be estimated using the Borg Scale.	Perceived exertion will be estimated during exercise on the ergometer bike on the day of the study.	No