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

NCT ID: NCT02335684

Last Updated: 2015-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CF-LVAD patients.

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

Group Type EXPERIMENTAL

CF-LVAD pump speed baseline.

Intervention Type OTHER

Submaximal exercise test with baseline pump speed.

CF-LVAD pump speed increased.

Intervention Type OTHER

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

Interventions

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CF-LVAD pump speed baseline.

Submaximal exercise test with baseline pump speed.

Intervention Type OTHER

CF-LVAD pump speed increased.

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Heart Foundation

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Finn Gustafsson

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Finn Gustafsson, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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University Hospital of Copenhagen; Rigshospitalet.

Copenhagen Oe, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-1-2013-103

Identifier Type: -

Identifier Source: org_study_id

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