Impact of LVAD Implantation on Micro- and Macrovascular Function

End Stage Heart Failure Clinical Trial

— LVAD  

Official title:

Impact of LVAD Implantation on Micro- and Macrovascular Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174133
• Other study ID #: LVAD
• Status: Completed
• Phase: N/A
• First received: June 24, 2014
• Last updated: March 9, 2015
• Start date: January 2014
• Est. completion date: July 2014

Study information

• Verified date: March 2015
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• End Stage Heart Failure

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macrovascular function measured by flow-mediated vasodilation (FMD)		3 months after implantation	No
Secondary	Microvascular function assessed by non-invasive laser Doppler imaging		3 months after implantation	No
Secondary	microparticles determined by Flow Cytometry		3 months after implantation	No