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

Starting soon · Not applicable

Conditions studied: Acute Heart Failure (AHF)

In brief

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).

Key facts

Study ID

NCT07392788

Run by

Centre Hospitalier Universitaire de Besancon

People needed

144

Starts

2026-04-01

Expected to finish

2028-02-01

Last updated by the study team

2026-02-06

Who can join

Age: 75 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 75 years
• ED admission for ADCHF with:
• Worsening CHF symptoms (dyspnea, fatigue, weight gain, edema)
• Objective signs of peripheral/pulmonary congestion
• Elevated natriuretic peptides:
• Sinus rhythm: BNP ≥ 400 pg/mL or NT-proBNP ≥ 1,600 pg/mL
• Atrial fibrillation: BNP ≥ 600 pg/mL or NT-proBNP ≥ 2,400 pg/mL
• Need for treatment intensification
• Expected hospitalization
• No prior gliflozin treatment
• Signed informed consent

You may not qualify if…

• Type 1 diabetes
• Chronic kidney disease (eGFR < 25ml/min/1.73m²)
• Cardiogenic shock
• Acute coronary syndrome (current or within 30 days)
• Severe valvular disease requiring surgery
• Recent/planned coronary intervention
• Known intolerance to study medication
• Legal protection measure or inability to consent
• Hospitalization in cardiology department
• Discharge home or to nursing home

Full record on ClinicalTrials.gov

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