NCT07392788Not yet recruiting
Early Gliflozin for Elderly Patients With Acute Decompensated Heart Failure in the Emergency Department
Early Gliflozin Treatment in Elderly Patient Hospitalized for Decompensated Chronic Heart Failure Admitted in the Emergency Room - a Feasibility Study
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 14 Nov 2024
- Start date
- Apr 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Diseases
- Heart failure
- NCT number
- NCT07392788
What you commit to
- Study type: Interventional
- Planned participants: 144
- From Apr 2026 to the primary completion date, Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known intolerance to study medication
Other illness
- Type 1 diabetes
- Acute coronary syndrome (current or within 30 days)
- Severe valvular disease requiring surgery
Lab values
- Chronic kidney disease (eGFR \< 25ml/min/1.73m²)
Other
- Cardiogenic shock
- Recent/planned coronary intervention
- Legal protection measure or inability to consent
- Hospitalization in cardiology department
- Discharge home or to nursing home
Who the study is looking for
- 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
Age in the registry: 75 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.