NCT07392788

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

Early Gliflozin Treatment in Elderly Patient Hospitalized for Decompensated Chronic Heart Failure Admitted in the Emergency Room - a Feasibility Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Rationale: Chronic heart failure (CHF) in elderly patients is associated with increased mortality, rehospitalization risk, and significant quality of life impairment. SGLT2 inhibitors (gliflozins) have demonstrated efficacy in reducing morbidity and mortality in stabilized CHF patients when initiated 24-72 hours after emergency department (ED) admission in cardiology units. However, most elderly CHF patients presenting to the ED with acute decompensation are hospitalized in non-cardiology departments and do not receive optimal therapeutic management including gliflozins, despite their potential significant benefit in this population. Hypothesis: Early initiation of gliflozins in the ED setting, without waiting for cardiology consultation, could avoid potential delays in optimal treatment for elderly patients with acute decompensated chronic heart failure (ADCHF). Study Design: This is a multicenter, prospective, randomized, open-label, parallel-group feasibility pilot study conducted over 30 months (including 12 months of recruitment) across 6 hospital emergency departments in France. The study will evaluate the overall feasibility of early ED initiation of gliflozins plus telephone follow-up compared to standard care in elderly patients admitted for ADCHF who are not previously treated with gliflozins.

Conditions

• Acute Heart Failure (AHF)

Interventions

Type	Name	Description
DRUG	Early initiation of dapagliflozin 10mg daily within 24h of emergency department admission	Early initiation of dapagliflozin 10mg daily within 24h of ED admission
OTHER	Telephone follow-up by cardiac nurse practitioner at 1 month	Telephone follow-up by cardiac nurse practitioner at 1 month
OTHER	Standard acute decompensated heart failure care	Standard acute decompensated heart failure care

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2028-02-01
• First posted: 2026-02-06
• Last updated: 2026-02-06