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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorCentre Hospitalier Universitaire de Besancon

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

Treatment groups

144 Participants
are divided into 2 treatment groups

Locations

This trial has no locations