Pronostic Value of Endothelial Dysfunction in Heart Failure | NCT02859636

Studies
Pronostic Value of Endothelial Dysfunction in Heart Failure

NCT02859636

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Terminated

Last Update Posted

Aug 9, 2016Estimated

Enrollment

7Actual

Phase

Not provided

Conditions

Heart Decompensation
Cardiac Failure

Interventions

Not provided

Countries

Not provided

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

Aug 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not enough inclusions

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Aug 2, 2016

First Submission Date that Met QC Criteria

Aug 4, 2016

First Posted Date

Aug 9, 2016Estimated

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

Aug 4, 2016

Last Update Posted Date

Aug 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The main objective is to evaluate the pronostic value of endothelial dysfonction in acute heart failure on a combined criteria associating cardiovascular mortality, nex hospitalisation for decompensated heart failure, cardiac graft or ventricular assistance 2 month and 1 year before acute 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

Retention

Enrollment

7Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MR Proadrenomedulline		6 months
catecholamins		6 months
		6 months
late endothelial progenitors		6 months
Peripheral tissular perfusion	Near infra-red spectroscopy	6 months
mortality		6 months
hospitalisation		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients hospitalized for acute heart fialure with Left Ventricular Ejection Fraction (LVEF) < 45 % on echocardiography

Exclusion Criteria:

Informed consent form not signed
Cardiogenic, septic or hemorragic shock
Acute coronary syndrom with elevated troponin
valvular surgery or aorto-coronary graft during next 3 months
Cancer
Pregnancy
life expectancy over than 1 year
chronic renal impairment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

81 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with more than 18 years and less than 81 years, hospitalized for acute heart failure with left ventricular impairment (LVEF < 45%)

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided