Iron Intravenous Therapy in Reducing the Burden of Severe Arrhythmias in Heart Failure With Reduced Ejection Fraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-20

Study Completion Date

2021-09-30

Brief Summary

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An open label,single-center, non-interventional prospective study with the aim on investigating the effect of intravenous ferric carboxymaltose in restoring iron status and reducing the risk of severe arrhythmic events in participants with iron deficiency and a reduced ejection fraction (HFrEF).

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Detailed Description

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Patients with HFrEF already scheduled to receive IV FCM to treat iron deficiency will be included in this registry trial. These patients undergo clinical examination, echocardiography, blood testing, 6-minute walking testing, cardiopulmonary exercise testing, cardiac implantable device interrogation, 24-hour Holter monitoring and quality of life quantification as part of standard clinical practice. This database will be extracted from clinical databases and stored on a separate, registry database. The study will examine the effect of IV FCM on patients' iron stores, arrhythmic burden, hospitalizations and clinical, echocardiographic, exercise-testing-derived and biological markers of disease severity such as 6-minute walking distance, peak VO2 consumption, LVEF and LV global longitudinal strain and NT-proBNP.

Conditions

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Ferric Carboxymaltose Heart Failure With Reduced Ejection Fraction Arrhythmias, Cardiac

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants

HFrEF patients undergoing iron therapy with intravenous carboxymaltose (FCM). FCM administered dosage as per clinical routine. FCM administration is repeated no sooner than 3 months than last therapy, based on repeat ferritin and transferrin saturation levels.

Ferric carboxymaltose

Intervention Type DRUG

Intravenous ferric carboxymaltose for the treatment of iron deficiency in HFrEF as per 2016 European Society of Cardiology Heart Failure guidelines.

Interventions

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Ferric carboxymaltose

Intravenous ferric carboxymaltose for the treatment of iron deficiency in HFrEF as per 2016 European Society of Cardiology Heart Failure guidelines.

Intervention Type DRUG

Other Intervention Names

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Ferinject

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of HFrEF (LVEF≤40%)
* Implanted cardiac implantable electronic device with at least 3 months of recorded arrhythmic history
* Patient is scheduled to receive IV ferric carboxymaltose to treat diagnosed iron deficiency

Exclusion Criteria

* Myocardial infarction, acute heart failure or life-threatening arrhythmias in the preceding 15 days
* Autoimmune disorders, cancer or other diseases other than heart failure that significantly affect patients' life expectancy, appetite and emotional status
* Known allergic reaction to ferric carboxymaltose.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No