Impact of LVAD Implantation on Micro- and Macrovascular F... | NCT02174133

Studies
Impact of LVAD Implantation on Micro- and Macrovascular Function

NCT02174133

Sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Status

Completed

Last Update Posted

Mar 10, 2015Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

End Stage Heart Failure

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jun 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jun 24, 2014

First Submission Date that Met QC Criteria

Jun 24, 2014

First Posted Date

Jun 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2015

Last Update Posted Date

Mar 10, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klinik für Kardiologie, Pneumologie und Angiologie, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, Heinrich-Heine University, DuesseldorfSponsor-Investigator

Lead Sponsor

Klinik für Kardiologie, Pneumologie und AngiologieOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with end stage heart failure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Heiss, MD	Division of Cardiology, Pulmonology and Vascular Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,		Düsseldorf		40225	Germany

Label	Type	Description	Intervention Names
patients after HTX
patients after LVAD implantation
patients with coronary heart disease
healthy volunteers