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Impact of LVAD Implantation on Micro- and Macrovascular Function

Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie (Other)
Overall Status
Completed
CT.gov ID
NCT02174133
Collaborator
(none)
60
Enrollment
1
Location
5.9
Duration (Months)
10.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of LVAD Implantation on Micro- and Macrovascular Function
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Jun 1, 2014
    Actual Study Completion Date :
    Jul 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    patients after HTX
    patients after LVAD implantation
    patients with coronary heart disease
    healthy volunteers

    Outcome Measures

    Primary Outcome Measures

    1. Macrovascular function measured by flow-mediated vasodilation (FMD) [3 months after implantation]

    Secondary Outcome Measures

    1. Microvascular function assessed by non-invasive laser Doppler imaging [3 months after implantation]

    2. microparticles determined by Flow Cytometry [3 months after implantation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf, Duesseldorf Germany 40225

    Sponsors and Collaborators

    • Klinik für Kardiologie, Pneumologie und Angiologie

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Klinik für Kardiologie, Pneumologie und Angiologie, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, Heinrich-Heine University, Duesseldorf
    ClinicalTrials.gov Identifier:
    NCT02174133
    Other Study ID Numbers:
    • LVAD
    First Posted:
    Jun 25, 2014
    Last Update Posted:
    Mar 10, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, Heinrich-Heine University, Duesseldorf
    left ventricular assist device
    endothelial function
    microvascular perfusion
    microparticles
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Mar 10, 2015