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NOT YET RECRUITING
NCT07392788
NA

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

Sponsor: Centre Hospitalier Universitaire de Besancon

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

75 Years - Any

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2026-04

Completion Date

2028-02

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

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