Iron in Congestive Heart Failure | NCT01837082

Studies
Iron in Congestive Heart Failure

NCT01837082

Sponsor

University of Ulm

Status

Terminated

Last Update Posted

May 13, 2016Estimated

Enrollment

18Actual

Phase

Phase 3

Conditions

Heart Failure
Iron Deficiency
Anemia

Interventions

ferric carboxymaltose
Placebo

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

ID	Type	Description	Link
2012-001134-33	EudraCT Number

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient recruitment

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Apr 17, 2013

First Submission Date that Met QC Criteria

Apr 17, 2013

First Posted Date

Apr 22, 2013Estimated

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

May 11, 2016

Last Update Posted Date

May 13, 2016Estimated

Name	Class
RWTH Aachen University	OTHER
Universitätsklinikum Hamburg-Eppendorf	OTHER

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 hypothesis to be tested is whether treatment with intravenous iron (ferric carboxymaltose) will improve left-ventricular ejection fraction in patients with heart failure and iron deficiency as determined by cardiac magnetic resonance imaging.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Iron	Active Comparator	ferric carboxymaltose	Drug: ferric carboxymaltose
Placebo	Placebo Comparator	Sodium chloride 0.9%	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ferric carboxymaltose	Drug		Iron	Ferinject
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary endpoint of the study is the change from baseline to week 12 in left-ventricular ejection fraction as determined by cardiac magnetic resonance imaging.		12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Congestive heart failure
At least 18 years of age
Iron deficiency
Dyspnea class II or III according to New York Heart Association
Left-ventricular ejection fraction ≤ 45%

Exclusion Criteria:

Known sensitivity to any of the products to be administered during dosing
Immediate need of transfusion
Patients presenting with an active infection
Thalassaemia
Other forms of microcytic anemia not caused by iron deficiency
History of acquired iron overload
Need for revascularization, ST-segment elevation myocardial infarction or Non-ST-segment elevation myocardial infarction during the past 3 months (at time of randomization)
Women who are pregnant or of childbearing age and not using medically acceptable effective contraception

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahir Karakas, MD	University of Ulm	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Aachen		Aachen		52074	Germany
University Heart Center Hamburg

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D000090463	Iron Deficiencies
D000740	Anemia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C522335	ferric carboxymaltose
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided