Impact of LVAD Implantation on Micro- and Macrovascular Function

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02174133

Acronym

LVAD

Enrollment

Registered

2014-06-25

Start date

2014-01-31

Completion date

2014-07-31

Last updated

2015-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Heart Failure

Keywords

left ventricular assist device, endothelial function, microvascular perfusion, microparticles

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results