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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Heart Failure (AHF)
• Intervention / Treatment: Drug: Early initiation of dapagliflozin 10mg daily within 24h of emergency department admission; Other: Telephone follow-up by cardiac nurse practitioner at 1 month; Other: Standard acute decompensated heart failure care

Detailed Description

Rationale: Chronic heart failure (CHF) in elderly patients is associated with increased mortality, rehospitalization risk, and significant quality of life impairment. SGLT2 inhibitors (gliflozins) have demonstrated efficacy in reducing morbidity and mortality in stabilized CHF patients when initiated 24-72 hours after emergency department (ED) admission in cardiology units. However, most elderly CHF patients presenting to the ED with acute decompensation are hospitalized in non-cardiology departments and do not receive optimal therapeutic management including gliflozins, despite their potential significant benefit in this population.

Hypothesis: Early initiation of gliflozins in the ED setting, without waiting for cardiology consultation, could avoid potential delays in optimal treatment for elderly patients with acute decompensated chronic heart failure (ADCHF).

Study Design: This is a multicenter, prospective, randomized, open-label, parallel-group feasibility pilot study conducted over 30 months (including 12 months of recruitment) across 6 hospital emergency departments in France. The study will evaluate the overall feasibility of early ED initiation of gliflozins plus telephone follow-up compared to standard care in elderly patients admitted for ADCHF who are not previously treated with gliflozins.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omide TAHERI, MD, PhD; Phone Number: 03 81 66 70 28; Email: omide.taheri@gmail.com
• Study Contact Backup: Name: Marie-France SERONDE, MD, PhD; Email: marie-france.seronde2@univ-fcomte.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 75 years

2. ED admission for ADCHF with:

   • Worsening CHF symptoms (dyspnea, fatigue, weight gain, edema)
   • Objective signs of peripheral/pulmonary congestion

   • Elevated natriuretic peptides:

     • Sinus rhythm: BNP ≥ 400 pg/mL or NT-proBNP ≥ 1,600 pg/mL
     • Atrial fibrillation: BNP ≥ 600 pg/mL or NT-proBNP ≥ 2,400 pg/mL
   • Need for treatment intensification
3. Expected hospitalization
4. No prior gliflozin treatment
5. Signed informed consent

Exclusion Criteria:

• Type 1 diabetes
• Chronic kidney disease (eGFR < 25ml/min/1.73m²)
• Cardiogenic shock
• Acute coronary syndrome (current or within 30 days)
• Severe valvular disease requiring surgery
• Recent/planned coronary intervention
• Known intolerance to study medication
• Legal protection measure or inability to consent
• Hospitalization in cardiology department
• Discharge home or to nursing home

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
Active Comparator: Control group; ✓ Standard acute decompensated heart failure care ONLY	Other: Standard acute decompensated heart failure care; Standard acute decompensated heart failure care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organizational feasibility: Implementation of procedures	Successful implementation of study procedures (yes/no). Binary assessment of whether study procedures were successfully implemented at each site.	3 months
Organizational feasibility: Patient flow assessment	Proportion of eligible patients successfully enrolled. Ratio of patients enrolled to patients screened, expressed as percentage.	3 months
Acceptability: Number of refusals	Number of patients refusing participation. Total count of eligible patients who declined to participate.	3 months
Acceptability: Reasons for refusal	Categories of refusal reasons. Qualitative categorization of stated reasons for study refusal.	3 months
Protocol adherence: Attrition rate	Proportion of participants completing the study protocol. Percentage of enrolled patients who complete all protocol requirements without withdrawal.	3 months
Protocol adherence: CRF completion rate	Case report form completion rate. Percentage of required case report form fields completed across all participants.	3 months
Protocol adherence: Telephone follow-up success rate	Proportion of patients successfully contacted by telephone at 1 month. Percentage of intervention group patients successfully reached for telephone follow-up by cardiac nurse practitioner.	1 month
Timeline adherence	Study timeline compliance (yes/no). Binary assessment of whether study met anticipated timeline for recruitment and follow-up phases.	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Study Chair: Frédéric MAUNY, MD, PhD, CHU Besançon; Study Chair: Marc PUYRAVEAU, MSc, CHU Besançon; Study Chair: Fatimata SARR, PhD, CHU Besançon; Study Chair: Thibaut DESMETTRE, MD, PhD, University Hospital, Geneva; Study Chair: Johan COSSUS, MD, CHU Besançon

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: elderly; emergency department; Feasibility study; acute heart failure; SGLT2 Inhibitors; Acute Decompensated Chronic Heart Failure
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Emergencies
• Other Study ID Numbers: 2024/882

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Plan Description:

De-identified individual participant data (IPD) that underlie the results reported in published articles, including the study protocol, statistical analysis plan, and informed consent form, may be shared upon reasonable request after study completion and primary publication.

Access Criteria:

• IPD Sharing Time Frame: After study completion and primary publication.
• IPD Sharing Access Criteria: IPD may be available to researchers who provide a methodologically sound proposal for academic purposes. Requests should be directed to [principal investigator email]. Requestors will need to sign a data access agreement and obtain approval from their local ethics committee. Data will be shared in compliance with EU GDPR and French data protection regulations.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No