Ferric Carboxymaltose Versus Placebo in Patients with Congestive Heart Failure

• Conditions: Congestive heart failure (CHF); MedDRA version: 16.1Level: LLTClassification code 10019284Term: Heart failure, congestiveSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001134-33-DE
• Lead Sponsor: niversitätsklinikum Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-28
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Congestive heart failure
-at least 18 years of age
-iron deficiency
-NYHA class II or III
-LVEF < 40%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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
-STEMI or Non-STEMI during the past 4 months
-women who are pregnant or of childbearing age and not using medically acceptable effective contraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified