Gliflofaster : Early Gliflozin Treatment in Elderly Patient Hospitalized for Decompensated Chronic Heart Failure Admitted in the Emergency Room - a Feasibility Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Universitaire

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-03-31

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

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.

Secondary objectives 1

1. Quantify the potential efficacy and possible side effects of early initiation of gliflozin treatment and telephone follow-up in the emergency department compared with standard care in elderly patients admitted to the emergency department for decompensated chronic heart failure and not treated with gliflozins.

Conditions and MedDRA coding

CHRONIC DECOMPENSATED HEART FAILURE

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Male or female, age ≥ 75 years
2. 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);
3. Patients considered for hospitalization;
4. No pre-existing treatment with gliflozins (empagliflozin or dapagliflozin);
5. Signed and dated informed consent

Exclusion criteria 15

1. Type 1 diabetes,
2. Chronic kidney disease (glomerular filtration rate < 25 ml/min/1.73 m²),
3. Cardiogenic shock,
4. Presence of acute coronary syndrome on ECG or within 30 days prior to randomization,
5. Any severe valvular heart disease that may require surgery during the study.
6. Percutaneous or surgical coronary intervention planned or performed within 30 days prior to randomization,
7. Known intolerance or history of hypersensitivity to the active substance or any of the excipients in the medication
8. Persons deprived of liberty,
9. Persons subject to legal protection measures, psychiatric care, persons admitted to a health or social care facility,
10. Individuals unable to express consent, follow instructions, or comply with follow-up procedures,
11. Any other medical condition that would put the patient at risk or could influence the results of the study,
12. Not affiliated with or not a beneficiary of a French social security system,
13. Subject is in the exclusion period of another study or listed in the “national volunteer registry.”
14. The patient is finally referred and admitted to the Cardiology Department.
15. The patient is ultimately referred to return home or to a residential care facility for dependent elderly people.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Organizational feasibility: setting up procedures, distribution of subjects in the flow chart. Acceptability based on refusal characteristics: number and reason. Adherence to the protocol and treatment: attrition, completeness of emergency CRF and IPA completion, proportion of patients contacted by telephone, compliance with the treatment and follow-up regimen. Compliance with the provisional timeline for the implementation of the study

Secondary endpoints 5

1. A composite endpoint comprising the following at 3 months: - All-cause mortality - Rehospitalization or unplanned visit for CHF - Deterioration in quality of life: 5-point decrease after 3 months of treatment compared to the value measured at hospital discharge (KCCQ-12)
2. Each of the three criteria of the composite criterion taken individually
3. A 50% decrease in NT-proBNP levels at 7 days (or upon discharge from hospital if earlier than 7 days) and at 3 months
4. Regression of clinical signs (dyspnea, asthenia, congestive signs) at 7 days (or upon discharge from hospital if earlier than 7 days) and at 3 months
5. Tolerance in relation to renal function: difference between glomerular filtration rate relative to baseline (at randomization) at 7 days (or at hospital discharge if earlier than 7 days) and at 3 months.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Universitaire

Sponsor organisation

Centre Hospitalier Regional Universitaire

Address

2 Place Saint Jacques, Cs 51804 Cs 51804

City

Besancon Cedex

Postcode

25030

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Universitaire

Contact name

Fatimata SALL

Public contact point

Organisation

Centre Hospitalier Regional Universitaire

Contact name

Noémie NMINEJ

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications