The Increase Study. Effect of Incremental Versus Fixed Pump on Peak Oxygen Consumption in Heart Failure Patients Supported With a Continuous Flow Left Venticular Assist Device

NCT ID: NCT01698398

Last Updated: 2014-02-11

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

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Brief Summary

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The purpose of the study is to examine the relationship between working capacity (peak oxygen consumption) and pump speed of continuous flow left ventricular assist devices (CF-LVADs)in heart failure patients. The hypothesis is that it is possible to increase peak oxygen consumption by incrementally increasing CF-LVAD pumpspeed during exercise.

The study population will consist of severe heart failure patients with CF-LVADs treated at The Heart Centre of Copenhagen University Hospital Rigshospitalet.

Detailed Description

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Conditions

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Heart Failure.

Study Design

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Allocation Method

RANDOMIZED

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CF-LVAD pumpspeed.

Optimal pumpspeed setting of CF-LVAD during exercise on ergometric bicycle.

Group Type EXPERIMENTAL

Incremental pump speed of CF-LVAD.

Intervention Type DEVICE

Peak oxygen consumption with fixed versus incremental pump speed.

Interventions

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Incremental pump speed of CF-LVAD.

Peak oxygen consumption with fixed versus incremental pump speed.

Intervention Type DEVICE

Other Intervention Names

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HeartMate II.

Eligibility Criteria

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Inclusion Criteria

* HeartMate II patients who underwent surgery and follow-up at The Heart Centre of Rigshospitalet.
* Heart failure in stable phase without the need for intravenous inotropic therapy.
* Ischemic and non-ischemic cardiomyopathy.

Exclusion Criteria

* Severe aortic insufficiency.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Locations

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Department of Cardiology, Copenhagen University Hospital, Rigshospitalet.

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Jung MH, Hansen PB, Sander K, Olsen PS, Rossing K, Boesgaard S, Russell SD, Gustafsson F. Effect of increasing pump speed during exercise on peak oxygen uptake in heart failure patients supported with a continuous-flow left ventricular assist device. A double-blind randomized study. Eur J Heart Fail. 2014 Apr;16(4):403-8. doi: 10.1002/ejhf.52.

Reference Type DERIVED
PMID: 24464845 (View on PubMed)

Other Identifiers

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H-1-2012-092

Identifier Type: -

Identifier Source: org_study_id

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