NCT02335684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

1.9 years

First QC Date

January 20, 2014

Last Update Submit

October 26, 2015

Conditions

Heart Failure

Keywords

Heart-assist devicesexercise capacity

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Perceived exertion

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

Other Outcomes (2)

  • Heart rate

    Heart rate will be measures during exercise.

  • Anaerobic threshold

    Anaerobic threshold is measured during exercise on the study day.

Study Arms (1)

CF-LVAD patients.

EXPERIMENTAL

Patients are compared with themselves during submaximal exercise testing with baseline pump speed vs. submaximal exercise testing with increased pump speed.

Other: CF-LVAD pump speed baseline.Other: CF-LVAD pump speed increased.

Interventions

CF-LVAD pump speed baseline.OTHER

Submaximal exercise test with baseline pump speed.

CF-LVAD patients.
CF-LVAD pump speed increased.OTHER

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

CF-LVAD patients.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic and non-ischemic cardiomyopathy patients with CF-LVADs,signed informed consent.

You may not qualify if:

  • Unstable patients, CF-LVAD implantation less than three months ago.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Copenhagen; Rigshospitalet.

Copenhagen Oe, 2100, Denmark

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Finn Gustafsson, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 12, 2015

Study Start

November 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

DK(1)