Trials / Unknown
UnknownNCT04974021
Iron Intravenous Therapy in Reducing the Burden of Severe Arrhythmias in Heart Failure With Reduced Ejection Fraction
An Open Label,Single-center, Non-interventional Prospective Study to Determine the Efficacy of Iron Therapy Using Intravenous Ferric Carboxymaltose and Its Effect in Reducing Arrhythmic Events in Participants With Iron Deficiency and HFrEF
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 106 (actual)
- Sponsor
- Aristotle University Of Thessaloniki · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
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).
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ferric carboxymaltose | Intravenous ferric carboxymaltose for the treatment of iron deficiency in HFrEF as per 2016 European Society of Cardiology Heart Failure guidelines. |
Timeline
- Start date
- 2019-06-20
- Primary completion
- 2021-08-30
- Completion
- 2021-09-30
- First posted
- 2021-07-23
- Last updated
- 2021-07-23
Locations
1 site across 1 country: Greece
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04974021. Inclusion in this directory is not an endorsement.