NCT01851889

Brief Summary

The purpose of the trial is to identify factors which can be used as guidance when optimizing continuous-flow left ventricular assist device (CF-LVAD) settings. The hypothesis of the study is that pulmonary capillary wedge pressure (PCWP) will change independently of left ventricular end diastolic diameter (LVEDD) when increasing pump speed ie ΔPCWP/RPM ≠ ΔLVEDD/RPM. The primary combined endpoint of the study is correlation between ΔPCWP and LVEDD slope under ramp testing in a cohort of "continuous-flow left ventricular assist device" heart failure patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.8 years 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

8 months

First QC Date

April 29, 2013

Last Update Submit

October 26, 2015

Conditions

Heart Failure.

Outcome Measures

Primary Outcomes (1)

  • Pulmonary capillary wedge pressure in mmHg.

    On trial day.

Study Arms (1)

CF-LVAD pump speed.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All heart failure patients with CF-LVAD at University Hospital of Copenhagen, Rigshospitalet.

You may qualify if:

  • Heart failure patients with HeartMate II (HM II) followed as outpatients at The Heart Centre at University Hospital of Copenhagen, Rigshospitalet.
  • Age \> 18 years.
  • Heart failure in stable phase without the need for intravenous inotropic therapy.
  • Ischemic or non-ischemic cardiomyopathy.
  • Signed informed consent.

You may not qualify if:

  • Unstable patients with the need for intravenous inotropic therapy.
  • Current hospitalization.
  • Implantation of HM II less than one month ago.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Rigshospitalet.

Copenhagen, Kbh Oe, 2100, Denmark

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Mette H Jung, MD

    Department of Cardiology B, University Hospital Rigshospitalet.

    PRINCIPAL INVESTIGATOR

  • Finn Gustafsson, MD, DMSc, PhD

    Department of Cardiology B, University Hospital Rigshospitalet.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DMSc, Ph.d., Chief Physician.

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 13, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

October 1, 2015

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

DK(1)