Iron in Congestive Heart Failure

NCT01837082 | Terminated Phase 3 DMC

• 2 other identifiers: iCHF_D.38742012-001134-33
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

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.

Conditions

Heart Failure; Iron Deficiency; Anemia

Keywords

Heart Failure; Iron Deficiency; Anemia; Ferric Carboxymaltose

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Iron

ACTIVE COMPARATOR

ferric carboxymaltose

Drug: ferric carboxymaltose

Placebo

PLACEBO COMPARATOR

Sodium chloride 0.9%

Drug: Placebo

Interventions

ferric carboxymaltose DRUG

Also known as: Ferinject

Iron

Placebo DRUG

Also known as: Sodium chloride 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulm: lead
• RWTH Aachen University: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (3)

University of Aachen

Aachen, 52074, Germany

Location

University Heart Center Hamburg

Hamburg, 20251, Germany

Location

University of Ulm

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Heart Failure; Iron Deficiencies; Anemia

Interventions

ferric carboxymaltose; Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mahir Karakas, MD

  University of Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 22, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

DE (3)