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

Sponsor
Centre Hospitalier Universitaire de Besancon
Study ID
NCT07392788
Status
Not Yet Recruiting

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Conditions

  • Acute Heart Failure (AHF)

Eligibility Criteria

Sex
ALL
Age
75 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Apr 30, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Intervention group
    * Early initiation of dapagliflozin 10mg daily within 24h of ED admission * Telephone follow-up by cardiac nurse practitioner at 1 month * Standard acute decompensated heart failure care
  • Active Comparator: Control group
    ✓ Standard acute decompensated heart failure care ONLY

Primary Outcome Measure

Organizational feasibility: Implementation of procedures [ Time Frame: 3 months ]

Central Contacts

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