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

October 26, 2015 updated by: Finn Gustafsson, Rigshospitalet, Denmark

Improving Functional Capacity in Heart Failure Patients Supported With Continuous-flow Left Ventricular Assist Devices. -Effects of Increased 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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen Oe, Denmark, 2100
        • University Hospital of Copenhagen; Rigshospitalet.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CF-LVAD patients.
Patients are compared with themselves during submaximal exercise testing with baseline pump speed vs. submaximal exercise testing with increased pump speed.
Submaximal exercise test with baseline pump speed.
Submaximal exercise test with increased pump speed (+800RPM).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Exercise time will be estimated only on the day of the study. No follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Perceived exertion will be estimated during exercise on the ergometer bike on the day of the study.

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Finn Gustafsson, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 9, 2015

First Posted (Estimate)

January 12, 2015

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on CF-LVAD pump speed baseline.

3
Subscribe