About this trial
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).
Eligibility criteria
Qualifiers
Age ≥ 75 years
Worsening CHF symptoms (dyspnea, fatigue, weight gain, edema)
Objective signs of peripheral/pulmonary congestion
Sinus rhythm: BNP ≥ 400 pg/mL or NT-proBNP ≥ 1,600 pg/mL
Disqualifiers
Type 1 diabetes
Chronic kidney disease (eGFR < 25ml/min/1.73m²)
Cardiogenic shock
Acute coronary syndrome (current or within 30 days)
Trial design
Treatments tested in this trial
- Early initiation of dapagliflozin 10mg daily within 24h of emergency department admission
- Telephone follow-up by cardiac nurse practitioner at 1 month
- Standard acute decompensated heart failure care