Suspended

iCHFIntravenous Iron (Ferric Carboxymaltose) for Improved Heart Function in Heart Failure Patients with Iron Deficiency

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Study Aim

This study aims to evaluate the effectiveness of Intravenous Iron (Ferric Carboxymaltose) in improving heart function, specifically the left-ventricular ejection fraction, in heart failure patients with iron deficiency over a 12-week period.

What is being tested

ferric carboxymaltose

+ Placebo

Drug
Who is being recruted

Cardiovascular Diseases+7

+ Heart Diseases

+ Hematologic Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversity of Ulm
Last updated: May 13, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

This study focuses on patients with congestive heart failure who also have iron deficiency. It aims to test whether a treatment using intravenous iron, specifically Ferric Carboxymaltose, can improve the heart's ability to pump blood effectively. This is measured by the left-ventricular ejection fraction. The study is important because it could potentially provide a new treatment option for heart failure patients with iron deficiency, helping to improve their heart function and overall health.

NCT01837082
Principal SponsorUniversity of Ulm
Last updated: May 13, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHematologic DiseasesHemic and Lymphatic DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesIron Metabolism DisordersIron DeficienciesAnemiaHeart Failure

Criteria

5 inclusion criteria required to participate
At least 18 years of age
Congestive heart failure
Dyspnea class II or III according to New York Heart Association
Iron deficiency
Show More Criteria
8 exclusion criteria prevent from participating
History of acquired iron overload
Immediate need of transfusion
Known sensitivity to any of the products to be administered during dosing
Need for revascularization, ST-segment elevation myocardial infarction or Non-ST-segment elevation myocardial infarction during the past 3 months (at time of randomization)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
ferric carboxymaltose

Group II

Placebo
Sodium chloride 0.9%

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

University of Aachen

Aachen, GermanyOpen University of Aachen in Google Maps

University Heart Center Hamburg

Hamburg, Germany

University of Ulm

Ulm, Germany
Suspended3 Study Centers