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

NCT07392788 | Not Yet Recruiting DMC

• 1 other identifier: 2024/882
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

acute heart failure; emergency department; elderly; SGLT2 Inhibitors; Feasibility study; Acute Decompensated Chronic Heart Failure

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

* 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; Other: Telephone follow-up by cardiac nurse practitioner at 1 month; Other: Standard acute decompensated heart failure care

Control group

ACTIVE COMPARATOR

✓ Standard acute decompensated heart failure care ONLY

Other: Standard acute decompensated heart failure care

Interventions

Telephone follow-up by cardiac nurse practitioner at 1 month OTHER

Telephone follow-up by cardiac nurse practitioner at 1 month

Intervention group

Standard acute decompensated heart failure care OTHER

Standard acute decompensated heart failure care

Control group; Intervention group

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

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

Intervention group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatimata SARR, PhD

  CHU Besançon

  STUDY CHAIR

• Frédéric MAUNY, MD, PhD

  CHU Besançon

  STUDY CHAIR

• Marc PUYRAVEAU, MSc

  CHU Besançon

  STUDY CHAIR

• Thibaut DESMETTRE, MD, PhD

  University Hospital, Geneva

  STUDY CHAIR

• Johan COSSUS, MD

  CHU Besançon

  STUDY CHAIR

Central Study Contacts

Omide TAHERI, MD, PhD

CONTACT

03 81 66 70 28; omide.taheri@gmail.com

Marie-France SERONDE, MD, PhD

CONTACT

marie-france.seronde2@univ-fcomte.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: February 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After study completion and primary publication.
• 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.