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

NCT07392788 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-02-06

No results posted yet for this study

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).

Conditions

  • Acute Heart Failure (AHF)

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Fatimata SARR, PhD · CHU Besançon

  • Frédéric MAUNY, MD, PhD · CHU Besançon

  • Marc PUYRAVEAU, MSc · CHU Besançon

  • Thibaut DESMETTRE, MD, PhD · University Hospital, Geneva

  • Johan COSSUS, MD · CHU Besançon

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-12-31
Completion
2028-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07392788 on ClinicalTrials.gov