Role of Macrophage Migration Inhibitory Factor (MIF) in H... | NCT03232671

Studies
Role of Macrophage Migration Inhibitory Factor (MIF) in Heart Failure

NCT03232671

Sponsor

University Hospital, Essen

Status

Completed

Last Update Posted

Nov 4, 2022Actual

Enrollment

180Actual

Phase

Not provided

Conditions

Heart Diseases

Interventions

MIF ELISA

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

Nov 2022

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

Mar 2016Actual

Primary Completion Date

Apr 2020Actual

Completion Date

Sep 1, 2020Actual

First Submitted Date

Jul 25, 2017

First Submission Date that Met QC Criteria

Jul 25, 2017

First Posted Date

Jul 28, 2017Actual

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

Nov 3, 2022

Last Update Posted Date

Nov 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Evaluating the additional value of Macrophage Migration Inhibitory factor (MIF) in cardiovascular diseases when assessed in clinical routine.

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

180Actual

Name	Type	Description	Arm Group Labels	Other Names
MIF ELISA	Diagnostic Test	Blood sample

Measure	Description	Time Frame
180 days mortality		180 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients presenting with symptoms of heart failure to the West-German Heart and Vascular Center according to the definition of the ESC 2016.

Patients fulfilling criteria for the diagnosis of HFrEF
Patients fulfilling criteria for the diagnosis of HFpEF
Patients fulfilling criteria for the diagnosis of HFmrEF
Patients presenting with dyspnea according to the NYHA classification I-IV, elevated BNP/NT-proBNP levels and echocardiographic findings of heart failure.

Exclusion Criteria:

Age < 18 years
Patients with symptoms of heart failure without fulfilling the criteria of the ESC guidelines 2016
Denial to participate

Accepts Healthy Volunteers

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

All patients presenting with symptoms of heart failure.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Lüdike, M.D.	University Hospital of Essen, Department of Cardiology and Vascular medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Essen		Essen	North Rhine-Westphalia	45147	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29728137	Derived	Luedike P, Alatzides G, Papathanasiou M, Heisler M, Pohl J, Lehmann N, Rassaf T. Predictive potential of macrophage migration inhibitory factor (MIF) in patients with heart failure with preserved ejection fraction (HFpEF). Eur J Med Res. 2018 May 4;23(1):22. doi: 10.1186/s40001-018-0321-1.