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NCT Number: NCT07392788

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

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).

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Key information

Conditions

Acute Heart Failure (AHF) Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 75 years
  • 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
  • Expected hospitalization
  • No prior gliflozin treatment
  • 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

Treatment and study plan

Early initiation of dapagliflozin 10mg daily within 24h of emergency department admission

Drug

Early initiation of dapagliflozin 10mg daily within 24h of ED admission

Telephone follow-up by cardiac nurse practitioner at 1 month

Other

Telephone follow-up by cardiac nurse practitioner at 1 month

Standard acute decompensated heart failure care

Other

Standard acute decompensated heart failure care

Primary outcomes

  1. Organizational feasibility: Implementation of procedures

    Time frame: 3 months

    Successful implementation of study procedures (yes/no). Binary assessment of whether study procedures were successfully implemented at each site.

  2. Organizational feasibility: Patient flow assessment

    Time frame: 3 months

    Proportion of eligible patients successfully enrolled. Ratio of patients enrolled to patients screened, expressed as percentage.

  3. Acceptability: Number of refusals

    Time frame: 3 months

    Number of patients refusing participation. Total count of eligible patients who declined to participate.

  4. Acceptability: Reasons for refusal

    Time frame: 3 months

    Categories of refusal reasons. Qualitative categorization of stated reasons for study refusal.

  5. Protocol adherence: Attrition rate

    Time frame: 3 months

    Proportion of participants completing the study protocol. Percentage of enrolled patients who complete all protocol requirements without withdrawal.

  6. Protocol adherence: CRF completion rate

    Time frame: 3 months

    Case report form completion rate. Percentage of required case report form fields completed across all participants.

  7. Protocol adherence: Telephone follow-up success rate

    Time frame: 1 month

    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.

  8. Timeline adherence

    Time frame: 3 months

    Study timeline compliance (yes/no). Binary assessment of whether study met anticipated timeline for recruitment and follow-up phases.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-France SERONDE, MD, PhD

CONTACT

[email protected]

Omide TAHERI, MD, PhD

CONTACT

[email protected]

03 81 66 70 28

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: GlifloFastER

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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