Early Gliflozin for Elderly Patients With Acute Decompensated Heart Failure in the Emergency Department
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early initiation of dapagliflozin 10mg daily within 24h of emergency department admission, Telephone follow-up by cardiac nurse practitioner at 1 month, Standard acute decompensated heart failure care.
- Who it may be relevant to
- Registry conditions: Acute Heart Failure (AHF). Basic parameters: from 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early Gliflozin Treatment in Elderly Patient Hospitalized for Decompensated Chronic Heart Failure Admitted in the Emergency Room - a Feasibility Study
Overview
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).
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.
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
Primary outcome measures
- Organizational feasibility: Implementation of procedures [Time frame: 3 months]
- Organizational feasibility: Patient flow assessment [Time frame: 3 months]
- Acceptability: Number of refusals [Time frame: 3 months]
- Acceptability: Reasons for refusal [Time frame: 3 months]
- Protocol adherence: Attrition rate [Time frame: 3 months]
- Protocol adherence: CRF completion rate [Time frame: 3 months]
- Protocol adherence: Telephone follow-up success rate [Time frame: 1 month]
- Timeline adherence [Time frame: 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07392788 · 2024/882