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OpenTrials
Completed

NCT Number: NCT02174133

Impact of LVAD Implantation on Micro- and Macrovascular Function

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.

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Key information

Conditions

End Stage Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Macrovascular function measured by flow-mediated vasodilation (FMD)

    Time frame: 3 months after implantation

Secondary outcomes

  1. Microvascular function assessed by non-invasive laser Doppler imaging

    Time frame: 3 months after implantation

  2. microparticles determined by Flow Cytometry

    Time frame: 3 months after implantation

Sponsors and collaborators

Lead sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Other

Registry information

Acronym: LVAD

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 25, 2014
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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