NCT02174133

Brief Summary

End stage heart failure is characterized by a critical inability of the heart to meet the organism's blood demand even under resting conditions. Heart transplantation (HTx) is the established therapeutic approach in the treatment of end stage heart failure and still the gold standard treatment. Left ventricular assist devices (LVADs) are considered as a vital therapeutic option to temporarily or permanently assist the failing circulation. The hemodynamic vascular consequences of implanting LVADs have not been studied in detail. The aim of the study is to investigate the effect of LVAD implantation compared to heart transplant (HTx) on micro- and macrovascular function in patients with end stage heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 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

January 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

5 months

First QC Date

June 24, 2014

Last Update Submit

March 9, 2015

Conditions

End Stage Heart Failure

Keywords

left ventricular assist deviceendothelial functionmicrovascular perfusionmicroparticles

Outcome Measures

Primary Outcomes (1)

  • Macrovascular function measured by flow-mediated vasodilation (FMD)

    3 months after implantation

Secondary Outcomes (2)

  • Microvascular function assessed by non-invasive laser Doppler imaging

    3 months after implantation

  • microparticles determined by Flow Cytometry

    3 months after implantation

Study Arms (4)

patients after HTX

patients after LVAD implantation

patients with coronary heart disease

healthy volunteers

Eligibility Criteria

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

patients with end stage heart failure

You may qualify if:

  • patients after HTX
  • patients after LVAD implantation
  • patients with stable coronary heart disease and normal systolic left ventricular function
  • healthy volunteers
  • written informed consent

You may not qualify if:

  • acute inflammation
  • cardiac arrhythmia
  • renal failure
  • malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,

Düsseldorf, 40225, Germany

Location

Study Officials

  • Christian Heiss, MD

    Division of Cardiology, Pulmonology and Vascular Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 25, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

DE(1)