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NOT YET RECRUITING
NCT06434025
PHASE3

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

Sponsor: Hospital de Clinicas de Porto Alegre

View on ClinicalTrials.gov

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.

Official title: Effect of Combination of Intravenous Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Patients With Heart Failure and Iron Deficiency.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

99

Start Date

2024-05-24

Completion Date

2026-11-24

Last Updated

2024-06-03

Healthy Volunteers

No

Interventions

DRUG

Iron Carboxymaltose

Iron Carboxymaltose 500 mg. 2 vials administered IV.

DRUG

Dapagliflozin 10mg Tab

Dapagliflozin 10mg Tab, PO, onde a day.

DRUG

Placebo of Iron Carboxymaltose

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

DRUG

Placebo of Dapagliflozin

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

Locations (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil