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

Heart Failure With Reduced Ejection Fraction Clinical Trial

— RESAFE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04974021
• Other study ID #: 219/12-3-19
• Status: Active, not recruiting
• Start date: June 20, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2021
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: September 30, 2021
• Est. primary completion date: August 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Ferric Carboxymaltose
• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

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

Locations

Country	Name	City	State
Greece	Hippokration General Hospital of Thessaloniki, Third Department of Cardiology (Aristotle University of Thessaloniki)	Thessaloníki	Macedonia

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin	Measured in g/dL, will be aggregated to form a composite primary endpoint of hemoglobin = 12g/dL, plasma ferritin = 50 ng/mL and transferrin saturation > 20%	6 and 12 months
Primary	Ferritin	Measured in ng/mL, will be aggregated to form a composite primary endpoint of hemoglobin = 12g/dL, plasma ferritin = 50 ng/mL and transferrin saturation > 20%	6 and 12 months
Primary	Transferrin saturation	Measured as a percentage, will be aggregated to form a composite primary endpoint of hemoglobin = 12g/dL, plasma ferritin = 50 ng/mL and transferrin saturation > 20%	6 and 12 months
Secondary	HF-related hospitalizations	Hospitalizations due to acute-on-chronic heart failure or worsening heart failure (compared with 12 months preceding treatment)	6 and 12 months
Secondary	N-terminal prohormone of brain natriuretic peptide (NT-proBNP)	NT-proBNP levels measured in serum (compared to baseline). NT-proBNP values are reported in pg/mL.	6 and 12 months
Secondary	Kansas City Cardiomyopathy Questionnaire	HF-specific QoL quantified with the Kansas City Cardiomyopathy Questionnaire (compared to baseline). The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status. The questionnaire ranges from 0% (worst possible QoL) to 100% (best possible QoL)	6 and 12 months
Secondary	EQ-5D-5L	General QoL is quantified with the EQ-5D-5L questionnaire (compared to baseline). EQ-5D-5L is a standardised measure of health-related quality of life. It contains a short descriptive system questionnaire and a visual analogue scale (EQ VAS). VAS ranges 0% to 100%.	6 and 12 months
Secondary	Ventricular tachycardias recorded by cardiac implantable electronic device	Compared with 12 months preceding recruitment.	6 and 12 months
Secondary	Non-sustained ventricular tachycardias recorded by cardiac implantable electronic device	Compared with 12 months preceding recruitment.	6 and 12 months
Secondary	Appropriate therapies administered by cardiac implantable electronic device	Compared with 12 months preceding recruitment.	6 and 12 months
Secondary	Appropriate atrial mode switch events recorded by cardiac implantable electronic device	Compared with 12 months preceding recruitment.	6 and 12 months
Secondary	Non-sustained ventricular tachycardias recorded during 24-hour Holter monitoring	Compared with baseline.	6 and 12 months
Secondary	Ventricular runs recorded during 24-hour Holter monitoring	Compared with baseline.	6 and 12 months
Secondary	Ventricular triple premature complexes during 24-hour Holter monitoring	Compared with baseline.	6 and 12 months
Secondary	Ventricular dual premature complexes during 24-hour Holter monitoring	Compared with baseline.	6 and 12 months
Secondary	Ventricular premature complexes during 24-hour Holter monitoring	Compared with baseline.	6 and 12 months
Secondary	Left ventricular end-diastolic volume index (LVEDVi)	Compared to baseline. Measured in mL/m^2.	6 and 12 months
Secondary	Left ventricular ejection fraction (LVEF)	Compared to baseline. Measured as a percentage.	6 and 12 months
Secondary	Left ventricular mass index (LVMi)	Compared to baseline. Measured in g/m^2.	6 and 12 months
Secondary	Left ventricular global longitudinal strain (LV GLS)	Compared to baseline. Measured as a percentage.	6 and 12 months
Secondary	Peak early diastolic tissue velocity (e')	?easured at the septal and lateral mitral annulus. Used to calculate E/e' ratio. Measured as m/s.	6 and 12 months
Secondary	E-wave mitral inflow velocity (E)	Used to calculate E/e' ratio. Measured as m/s.	6 and 12 months
Secondary	Right ventricular fractional area change (RV FAC)	Compared to baseline. Measured as a percentage.	6 and 12 months
Secondary	6-minute walking distance (6MWD)	Distance recorded during six-minute walk testing. Measured in meters. Compared to baseline.	6 and 12 months
Secondary	Maximal oxygen consumption (VO2 max)	Maximal oxygen consumption recorded during cardiopulmonary exercise testing. Measured in mL/kg/min. Compared to baseline.	6 and 12 months
Secondary	Minute ventilation/carbon dioxide production slope (VE/VCO2 slope)	The VE/VCO2 slope recorded during cardiopulmonary exercise testing. Absolute unit. Compared to baseline.	6 and 12 months
Secondary	End-tidal carbon dioxide at anaerobic threshold (etCO2-AT)	Recorded during cardiopulmonary exercise testing. Measured in mmHg. Compared to baseline.	6 and 12 months
Secondary	Late potentials	Signal Averaged ECG (SAECG) enables the detection of late potentials. Specialist software automatically performs the detection of late potentials in patients' Holter monitor recordings.	6 and 12 months
Secondary	Microvolt T-wave Alternans (TWA)	Specialist software quantifies microvolt TWA voltage in patients' Holter monitor recordings. microvolt TWA is measured in µV.	6 and 12 months
Secondary	Heart rate turbulence (HRT)	Heart rate turbulence (HRT) is the baroreflex-mediated short-term oscillation of cardiac cycle lengths after spontaneous ventricular premature complexes. Specialist software detects abnormal HRT in patients' Holter monitor recordings. The existence of abnormal heart rate turbulence is a nominal variable.	6 and 12 months
Secondary	Deceleration capacity	(Heart rate) deceleration capacity is a measurement of autonomic nerve regulation in heart failure. Specialist software quantifies deceleration capacity, which is measured in milliseconds (ms).	6 and 12 months