GLIFLOFASTER : EARLY GLIFLOZIN TREATMENT IN ELDERLY PATIENT HOSPITALIZED FOR DECOMPENSATED CHRONIC HEART FAILURE ADMITTED IN THE EMERGENCY ROOM - A FEASIBILITY STUDY
Key facts
- Where
- Besancon Cedex, Colmar Cedex, Dijon, Reims Cedex, Strasbourg és Trévenans, FranciaországSee the 6 sites
- Phase
- 4. fázis
Where in Franciaország
- Centre Hospitalier Regional UniversitaireBesancon Cedex, FranciaországToborzás még nem indult
- Centre Hospitalier De ColmarColmar Cedex, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de DijonDijon, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire ReimsReims Cedex, FranciaországToborzás még nem indult
- Les Hopitaux Universitaires de StrasbourgStrasbourg, FranciaországToborzás még nem indult
- Hôpital Nord Franche-ComtéTrévenans, FranciaországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Regional Universitaire
- Trial code
- EU 2025-521101-40-00
- Record updated
- 2026. március 31.
- Original description
Assess the overall feasibility of a prospective randomized study comparing early initiation of gliflozin treatment with telephone counseling in the emergency department with standard care in elderly patients admitted to the emergency department for decompensated chronic heart failure and not treated with gliflozins.Read full original descriptionShow less
Assess the overall feasibility of a prospective randomized study comparing early initiation of gliflozin treatment with telephone counseling in the emergency department with standard care in elderly patients admitted to the emergency department for decompensated chronic heart failure and not treated with gliflozins.
Inclusion: Male or female, age ≥ 75 years; Admitted to the emergency department for acute decompensated heart failure, diagnosed by the emergency physician based on a range of factors including: (i) Worsening symptoms of chronic heart failure - worsening dyspnea or dyspnea at rest - progressive asthenia - weight gain - worsening of edema/abdominal distension/anasarca (ii) AND objective signs or diagnostic tests consistent with peripheral and/or pulmonary congestion - jugular venous distension - bilateral crackles on pulmonary auscultation - presence of S3 gallop on cardiac auscultation - ascites - hepatomegaly - peripheral edema - radiological and/or ultrasound signs of pulmonary congestion - dilatation of the inferior vena cava (iii) AND elevated natriuretic peptides (BNP or NT-proBNP): a. For patients in sinus rhythm: BNP ≥ 400 pg/mL or NT-proBNP ≥ 1,600 pg/mL b. For patients with atrial fibrillation: BNP ≥ 600 pg/mL or NT-proBNP ≥ 2,400 pg/mL) (iv) AND need for treatment intensification upon admission (increased doses of oral diuretics, addition of a second diuretic, or initiation of intravenous diuretic therapy); Patients considered for hospitalization; No pre-existing treatment with gliflozins (empagliflozin or dapagliflozin); Signed and dated informed consent.
Exclusion: Presence of acute coronary syndrome on ECG or within 30 days prior to randomization,; Percutaneous or surgical coronary intervention planned or performed within 30 days prior to randomization,; Type 1 diabetes,; Any other medical condition that would put the patient at risk or could influence the results of the study,; Chronic kidney disease (glomerular filtration rate < 25 ml/min/1.73 m²),; Any severe valvular heart disease that may require surgery during the study; Known intolerance or history of hypersensitivity to the active substance or any of the excipients in the medication; Persons subject to legal protection measures, psychiatric care, persons admitted to a health or social care facility,; Individuals unable to express consent, follow instructions, or comply with follow-up procedures,; Not affiliated with or not a beneficiary of a French social security system,; Subject is in the exclusion period of another study or listed in the “national volunteer registry.”; The patient is finally referred and admitted to the Cardiology Department; The patient is ultimately referred to return home or to a residential care facility for dependent elderly people; Cardiogenic shock,; Persons deprived of liberty,.