IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency

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

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-24

Study Completion Date

2026-11-24

Brief Summary

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Background. Treatment with intravenous iron has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) and iron deﬁciency. However, the mechanisms underlying these beneﬁcial eﬀects remain unknown. SGLT2i seem to alter hematocrit and other hematological markers or iron content.

This study aims to measure cardiac magnetic resonance changes in myocardial iron content and in left ventricular function after administration of intravenous iron with and without the concomitant use of SGLT2 inhibitor in patients with HFrEF and iron deﬁciency.

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Detailed Description

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Background. Treatment with intravenous iron has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) and iron deﬁciency. However, the mechanisms underlying these beneﬁcial eﬀects remain unknown. SGLT2i seem to alter hematocrit and other hematological markers or iron content. This study aims to measure cardiac magnetic resonance changes in myocardial iron content after administration of intravenous iron and to assess changes in left ventricular function in patients with HFrEF and iron deﬁciency.

Methods. Ninety-nine outpatient with symptomatic HFrEF, left ventricular ejection fraction (LVEF) \<40%, SGLT2i naive, and iron deﬁciency will be assigned, to receive intravenous iron + SGLT2i; or intravenous iron + placebo of SGLT2i; or placebo of both therapies for 30 days. Myocardial iron will be evaluated by T2-star (T2\*) cardiac magnetic resonance (CMR) sequencing before intravenous iron infusion. After 30 days, all patients will be reassessed by T2\* CMR sequencing. The primary endpoint will be changes in LVEF and myocardial iron content at 30 days. Secondary endpoints will include correlations of these changes with myocardial iron content, functional capacity, quality of life, and cardiac biomarkers.

Conclusions. This study will determine the eﬀect of ferric carboxymaltose and its combination with SGLT2i on LVEF and its relationship with measures of myocardial iron content, functional capacity, and biomarkers in HFrEF and iron deﬁciency.

Conditions

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Heart Failure, Systolic Iron Deficiencies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

HFrEF, LVEF \<40%, SGLT2i naive, and iron deﬁciency. Assigned to receive:

1. intravenous iron + SGLT2i;
2. intravenous iron + placebo of SGLT2i;
3. placebo of both therapies.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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ferric carboxymaltose + SGLT2 inhibitor

Patients will receive 2 vials of ferric carboxymaltose 500 mg (Ferinject® 500 mg, Vifor-Pharma) IV, once; and Dapagliflozin 10 mg PO, once a day, for 30 days.

Group Type EXPERIMENTAL

Iron Carboxymaltose

Intervention Type DRUG

Iron Carboxymaltose 500 mg. 2 vials administered IV.

Dapagliflozin 10mg Tab

Intervention Type DRUG

Dapagliflozin 10mg Tab, PO, onde a day.

ferric carboxymaltose + placebo of SGLT2 inhibitor

Patients will receive 2 vials of ferric carboxymaltose 500 mg (Ferinject® 500 mg, Vifor-Pharma) IV, once; and placebo PO, once a day, for 30 days.

Group Type ACTIVE_COMPARATOR

Iron Carboxymaltose

Intervention Type DRUG

Iron Carboxymaltose 500 mg. 2 vials administered IV.

Placebo of Dapagliflozin

Intervention Type DRUG

Equal shape and appearance tab as the tab containing Dapagliflozin 10 mg

Placebo of ferric carboxymaltose and placebo of SGLT2 inhibitor

Patients will receive 2 vials of placebo IV, once; and placebo PO, once a day, for 30 days.

Group Type PLACEBO_COMPARATOR

Placebo of Iron Carboxymaltose

Intervention Type DRUG

Solution Sodium Chloride 0,9% 100 ml, IV, once.

Placebo of Dapagliflozin

Intervention Type DRUG

Equal shape and appearance tab as the tab containing Dapagliflozin 10 mg

Interventions

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Iron Carboxymaltose

Iron Carboxymaltose 500 mg. 2 vials administered IV.

Intervention Type DRUG

Dapagliflozin 10mg Tab

Dapagliflozin 10mg Tab, PO, onde a day.

Intervention Type DRUG

Placebo of Iron Carboxymaltose

Solution Sodium Chloride 0,9% 100 ml, IV, once.

Intervention Type DRUG

Placebo of Dapagliflozin

Equal shape and appearance tab as the tab containing Dapagliflozin 10 mg

Intervention Type DRUG

Other Intervention Names

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Ferinject Forxiga Saline

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or over;
2. Ejection fraction (EF) ≤40%, estimated by color Doppler echocardiography or CMR or radionuclide ventriculography;
3. Serum ferritin \<100 µg/L or serum ferritin between 100 and 299 µg/L and transferrin saturation \<20%;
4. Serum hemoglobin between 9.5 and 13.5 mg/dL;
5. Patients must be SGLT2 naive;
6. Informed consent form (ICF) signed.

Exclusion Criteria

1. Kidney disease requiring dialysis or chronic kidney disease not requiring dialysis with an estimated glomerular ﬁltration rate \<30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation;
2. Severe primary valve disease;
3. Acute coronary syndrome requiring cardiac surgery or coronary artery bypass surgery in the past 3 months;
4. Patients already being treated for some type of non-iron deﬁciency anemia;
5. Blood transfusion within 30 days prior to CMR examination;
6. Patients with a pacemaker, cardiac resynchronization therapy, or implantable defibrillator;
7. Diagnosis of hemochromatosis.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No