Impact of LVAD Implantation on Micro- and Macrovascular Function (LVAD)

March 9, 2015 updated by: Klinik für Kardiologie, Pneumologie und Angiologie
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Duesseldorf, Germany, 40225
        • Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with end stage heart failure

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
healthy volunteers
patients after HTX
patients after LVAD implantation
patients with coronary heart disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Macrovascular function measured by flow-mediated vasodilation (FMD)
Time Frame: 3 months after implantation
3 months after implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Microvascular function assessed by non-invasive laser Doppler imaging
Time Frame: 3 months after implantation
3 months after implantation
microparticles determined by Flow Cytometry
Time Frame: 3 months after implantation
3 months after implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Investigators

  • Principal Investigator: Christian Heiss, MD, Division of Cardiology, Pulmonology and Vascular Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LVAD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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