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GLIFLOFASTER : EARLY GLIFLOZIN TREATMENT IN ELDERLY PATIENT HOSPITALIZED FOR DECOMPENSATED CHRONIC HEART FAILURE ADMITTED IN THE EMERGENCY ROOM - A FEASIBILITY STUDY
EU CTIS ID: 2025-521101-40-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Type 1 diabetes,
- Individuals unable to express consent, follow instructions, or comply with follow-up procedures,
- Any other medical condition that would put the patient at risk or could influence the results of the study,
- 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.
See the full eligibility criteria
- 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
- Type 1 diabetes,
- Individuals unable to express consent, follow instructions, or comply with follow-up procedures,
- Any other medical condition that would put the patient at risk or could influence the results of the study,
- 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.
- Chronic kidney disease (glomerular filtration rate < 25 ml/min/1.73 m²),
- Cardiogenic shock,
- Presence of acute coronary syndrome on ECG or within 30 days prior to randomization,
- Any severe valvular heart disease that may require surgery during the study.
- Percutaneous or surgical coronary intervention planned or performed within 30 days prior to randomization,
- Known intolerance or history of hypersensitivity to the active substance or any of the excipients in the medication
- Persons deprived of liberty,
- Persons subject to legal protection measures, psychiatric care, persons admitted to a health or social care facility,
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.