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

NCT06434025 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: 78861724.0.0000.53272023-0428
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure, Systolic; Iron Deficiencies

Keywords

heart failure; iron deficiency; SGLT2 inhibitor; intravenous iron; clinical trial

Outcome Measures

Primary Outcomes (1)

• left ventricular function assessed (LVEF) by CMR.

  LVEF assessed by Cardiac Magnetic Resonance

  30 days

Secondary Outcomes (2)

• Myocardial iron content assessed by T2* CMR

  30 days

• myocardial strain assessed by T2* CMR

  30 days

Other Outcomes (7)

• six minute walk test (6MWT)

  30 days

• NT-proBNP

  30 days

• MLHFQ

  30 days

Study Arms (3)

ferric carboxymaltose + SGLT2 inhibitor

EXPERIMENTAL

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.

Drug: Iron Carboxymaltose; Drug: Dapagliflozin 10mg Tab

ferric carboxymaltose + placebo of SGLT2 inhibitor

ACTIVE COMPARATOR

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.

Drug: Iron Carboxymaltose; Drug: Placebo of Dapagliflozin

Placebo of ferric carboxymaltose and placebo of SGLT2 inhibitor

PLACEBO COMPARATOR

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

Drug: Placebo of Iron Carboxymaltose; Drug: Placebo of Dapagliflozin

Interventions

Iron Carboxymaltose DRUG

Iron Carboxymaltose 500 mg. 2 vials administered IV.

Also known as: Ferinject

ferric carboxymaltose + SGLT2 inhibitor; ferric carboxymaltose + placebo of SGLT2 inhibitor

Dapagliflozin 10mg Tab DRUG

Dapagliflozin 10mg Tab, PO, onde a day.

Also known as: Forxiga

ferric carboxymaltose + SGLT2 inhibitor

Placebo of Iron Carboxymaltose DRUG

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

Also known as: Saline

Placebo of ferric carboxymaltose and placebo of SGLT2 inhibitor

Placebo of Dapagliflozin DRUG

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

Placebo of ferric carboxymaltose and placebo of SGLT2 inhibitor; ferric carboxymaltose + placebo of SGLT2 inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• Severe primary valve disease;
• Acute coronary syndrome requiring cardiac surgery or coronary artery bypass surgery in the past 3 months;
• Patients already being treated for some type of non-iron deficiency anemia;
• Blood transfusion within 30 days prior to CMR examination;
• Patients with a pacemaker, cardiac resynchronization therapy, or implantable defibrillator;
• Diagnosis of hemochromatosis.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Vifor Pharma: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90450120, Brazil

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Iron Deficiencies; Heart Failure

Interventions

ferric carboxymaltose; dapagliflozin; Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• LUIS BECK DA SILVA, MD ScD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LUIS BECK DA SILVA, MD ScD

CONTACT

55 51 997330870; lbneto@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: May 24, 2024
• Primary Completion (Estimated): May 24, 2026
• Study Completion (Estimated): November 24, 2026
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)