NCT01698398

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

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

October 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Last Updated

February 11, 2014

Status Verified

October 1, 2012

Enrollment Period

3 months

First QC Date

October 2, 2012

Last Update Submit

February 10, 2014

Conditions

Heart Failure.

Outcome Measures

Primary Outcomes (1)

  • Peak oxygen consumption.

    ml oxygen/minute/kg

    Day 1

Secondary Outcomes (1)

  • Working capacity.

    Day 1

Other Outcomes (1)

  • Exercise time (minutes), anerobic threshold.

    Day 1

Study Arms (1)

CF-LVAD pumpspeed.

EXPERIMENTAL

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

Device: Incremental pump speed of CF-LVAD.

Interventions

Incremental pump speed of CF-LVAD.DEVICE

Peak oxygen consumption with fixed versus incremental pump speed.

Also known as: HeartMate II.
CF-LVAD pumpspeed.

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Severe aortic insufficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Copenhagen University Hospital, Rigshospitalet.

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 24464845DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 3, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2013

Last Updated

February 11, 2014

Record last verified: 2012-10

Locations

DK(1)