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Ferric CarboxymaltoseRESAFENCT04974021

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

An observational study of Ferric Carboxymaltose and Heart Failure With Reduced Ejection Fraction, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ferric carboxymaltose
Type of treatment
Injection or infusion
How many people
106 participants
Where
1 siteGreece
Study dates
20 Jun 2019to 30 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients with heart failure and reduced ejection fraction, cardiac implantable electronic devices and iron deficiency visiting the outpatient HF clinic of the Third Department of Cardiology AUTh

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Hippokration General Hospital of Thessaloniki, Third Department of Cardiology (Aristotle University of Thessaloniki)

    Thessaloniki, Macedonia, GR54642

Other trials in Greece

About this study

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

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).

Read the 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.

Being tested
Ferric carboxymaltose
Keywords
ferric carboxymaltose, heart failure, arrhythmias
Medical subject headings
Arrhythmias, Cardiac, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferric carboxymaltoseDrug

    Also called Ferinject

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

Study groups in NCT04974021
Study groupRoleWhat they receive
ParticipantsHFrEF 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.
Receives: Drug: Ferric carboxymaltose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%

    Measured: 6 and 12 months

  2. 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%

    Measured: 6 and 12 months

  3. 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%

    Measured: 6 and 12 months

Secondary outcomes (28)

  1. HF-related hospitalizations

    Hospitalizations due to acute-on-chronic heart failure or worsening heart failure (compared with 12 months preceding treatment)

    Measured: 6 and 12 months

  2. 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.

    Measured: 6 and 12 months

  3. 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)

    Measured: 6 and 12 months

  4. 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%.

    Measured: 6 and 12 months

  5. Ventricular tachycardias recorded by cardiac implantable electronic device

    Compared with 12 months preceding recruitment.

    Measured: 6 and 12 months

  6. Non-sustained ventricular tachycardias recorded by cardiac implantable electronic device

    Compared with 12 months preceding recruitment.

    Measured: 6 and 12 months

  7. Appropriate therapies administered by cardiac implantable electronic device

    Compared with 12 months preceding recruitment.

    Measured: 6 and 12 months

  8. Appropriate atrial mode switch events recorded by cardiac implantable electronic device

    Compared with 12 months preceding recruitment.

    Measured: 6 and 12 months

  9. Non-sustained ventricular tachycardias recorded during 24-hour Holter monitoring

    Compared with baseline.

    Measured: 6 and 12 months

  10. Ventricular runs recorded during 24-hour Holter monitoring

    Compared with baseline.

    Measured: 6 and 12 months

  11. Ventricular triple premature complexes during 24-hour Holter monitoring

    Compared with baseline.

    Measured: 6 and 12 months

  12. Ventricular dual premature complexes during 24-hour Holter monitoring

    Compared with baseline.

    Measured: 6 and 12 months

  13. Ventricular premature complexes during 24-hour Holter monitoring

    Compared with baseline.

    Measured: 6 and 12 months

  14. Left ventricular end-diastolic volume index (LVEDVi)

    Compared to baseline. Measured in mL/m^2.

    Measured: 6 and 12 months

  15. Left ventricular ejection fraction (LVEF)

    Compared to baseline. Measured as a percentage.

    Measured: 6 and 12 months

  16. Left ventricular mass index (LVMi)

    Compared to baseline. Measured in g/m^2.

    Measured: 6 and 12 months

  17. Left ventricular global longitudinal strain (LV GLS)

    Compared to baseline. Measured as a percentage.

    Measured: 6 and 12 months

  18. Peak early diastolic tissue velocity (e')

    Μeasured at the septal and lateral mitral annulus. Used to calculate E/e' ratio. Measured as m/s.

    Measured: 6 and 12 months

  19. E-wave mitral inflow velocity (E)

    Used to calculate E/e' ratio. Measured as m/s.

    Measured: 6 and 12 months

  20. Right ventricular fractional area change (RV FAC)

    Compared to baseline. Measured as a percentage.

    Measured: 6 and 12 months

  21. 6-minute walking distance (6MWD)

    Distance recorded during six-minute walk testing. Measured in meters. Compared to baseline.

    Measured: 6 and 12 months

  22. Maximal oxygen consumption (VO2 max)

    Maximal oxygen consumption recorded during cardiopulmonary exercise testing. Measured in mL/kg/min. Compared to baseline.

    Measured: 6 and 12 months

  23. Minute ventilation/carbon dioxide production slope (VE/VCO2 slope)

    The VE/VCO2 slope recorded during cardiopulmonary exercise testing. Absolute unit. Compared to baseline.

    Measured: 6 and 12 months

  24. End-tidal carbon dioxide at anaerobic threshold (etCO2-AT)

    Recorded during cardiopulmonary exercise testing. Measured in mmHg. Compared to baseline.

    Measured: 6 and 12 months

  25. 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.

    Measured: 6 and 12 months

  26. Microvolt T-wave Alternans (TWA)

    Specialist software quantifies microvolt TWA voltage in patients' Holter monitor recordings. microvolt TWA is measured in μV.

    Measured: 6 and 12 months

  27. 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.

    Measured: 6 and 12 months

  28. 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).

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2021
  2. Study start20 Jun 2019
  3. Primary completion30 Aug 2021 (estimated)
  4. Study completion30 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04974021
Sponsor's protocol ID
219/12-3-19
Acronym
RESAFE
Status last verified
Jul 2021
First submitted
5 Jul 2021
Last updated
23 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Ferric Carboxymaltose and Heart Failure With Reduced Ejection Fraction, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin (time frame: 6 and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04974021.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.

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