Impact of LVAD Implantation on Micro- and Macrovascular Function

NCT ID: NCT02174133

Last Updated: 2015-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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End Stage Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients after HTX

No interventions assigned to this group

patients after LVAD implantation

No interventions assigned to this group

patients with coronary heart disease

No interventions assigned to this group

healthy volunteers

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Klinik für Kardiologie, Pneumologie und Angiologie

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Kardiologie, Pneumologie und Angiologie

Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Christian Heiss, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonology and Vascular Medicine

Locations

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Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,

Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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LVAD

Identifier Type: -

Identifier Source: org_study_id

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