Trial intelligence / Profile preview

Dapagliflozin in Heart Failure with Reduced or Mildly Reduced Ejection Fraction

NCT05420285Phase 2

Key facts

Status: Unknown
Start: Jun 2022
Primary completion: Sep 2023
Countries: 1
Sponsor: Assistance publique - Hôpitaux de Paris
Modality: Small Molecules

Drugs: dapagliflozin
Conditions: heart failure with reduced ejection fraction (HFrEF)heart failure with mildly reduced ejection fraction (HFmrEF)

Overview

Phase 2, open-label, single-arm trial of dapagliflozin in heart failure with reduced ejection fraction (HFrEF) and heart failure with mildly reduced ejection fraction (HFmrEF), sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoint: Left ventricular extracellular mass index at 6 months. Status: unknown.

Design

1 arm

Study design: Non-randomizedOpen-label

Dapagliflozin
Dapagliflozin 10 mg once daily for 6 months

Who it enrols

Adult patients with heart failure (NYHA II-IV) and reduced or mildly reduced ejection fraction (LVEF <= 50%) on optimal medical therapy, excluding those with BMI > 40, eGFR < 30, or uncontrolled diabetes.

Endpoints

Primary

Left ventricular extracellular mass index6 months

Secondary

Myocardial morphology6 months
Left ventricular ejection fraction6 months
Right ventricular ejection fraction6 months
Left atrial ejection fraction6 months
Peak global longitudinal strain6 months
Peak radial strain6 months
Peak circumferential strain6 months
Left atrial peak circumferential strain6 months

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