Clinical Trial

Early Gliflozin for Elderly Patients With Acute Decompensated Heart Failure in the Emergency Department

Study acronym: GlifloFastER
Not Yet Recruiting
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Summary
Background: SGLT2 inhibitors reduce CHF morbidity/mortality but are underutilized in elderly patients with acute decompensated CHF (ADCHF) admitted outside cardiology departments. Objective: Assess feasibility of early ED-initiated gliflozin therapy in elderly ADCHF patients. Design: Multicenter, randomized, open-label pilot study; N=144 patients (72 per arm) across 6 EDs over 30 months. Population: Age ≥75 years, ED admission for ADCHF (symptomatic worsening, congestion, elevated natriuretic peptides), gliflozin-naïve, requiring hospitalization. Key Exclusions: Type 1 diabetes, eGFR \<25 mL/min/1.73m², cardiogenic shock, recent ACS, cardiology ward admission. Intervention: Treatment: Dapagliflozin 10mg daily within 24h + cardiac nurse telephone follow-up at 1 month Control: Standard care only Primary Outcome: Feasibility (organizational implementation, acceptability, protocol adherence, timeline compliance). Follow-up: 7-day visit (clinical assessment, NT-proBNP, echocardiography) and 3-month cardiology consultation (mortality, rehospitalization, QoL, biomarkers, safety parameters).
Trial Details
NCT Number NCT07392788
Lead Sponsor Centre Hospitalier Universitaire de Besancon
Conditions Acute Heart Failure (AHF)
Enrollment 144 participants
Start Date 2026-04
Primary Completion 2027-12 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-02-06