Acute Heart Failure (AHF)GlifloFastERNCT07392788
Early Gliflozin for Elderly Patients With Acute Decompensated Heart Failure in the Emergency Department
A study testing Early initiation of dapagliflozin 10mg daily within 24h of emergency department admission, Telephone follow-up by cardiac nurse practitioner at 1 month and Standard acute decompensated heart failure care in people with Acute Heart Failure (AHF), run by Centre Hospitalier Universitaire de Besancon.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Acute Heart Failure (AHF)
- What is being tested?
- Early initiation of dapagliflozin 10mg daily within 24h of emergency department admission, Telephone follow-up by cardiac nurse practitioner at 1 month and Standard acute decompensated heart failure care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 10Show fewer
- Known intolerance to study medication
- Legal protection measure or inability to consent
- Hospitalization in cardiology department
- Discharge home or to nursing home
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marie-France SERONDE, MD, PhD contact
About this study
Official title: Early Gliflozin Treatment in Elderly Patient Hospitalized for Decompensated Chronic Heart Failure Admitted in the Emergency Room - a Feasibility Study
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.
Read more
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).
Read the 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.
- Conditions
- Acute Heart Failure (AHF)
- Being tested
- 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
- Keywords
- acute heart failure, emergency department, elderly, SGLT2 Inhibitors, Feasibility study, Acute Decompensated Chronic Heart Failure
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early initiation of dapagliflozin 10mg daily within 24h of emergency department admissionDrug
Early initiation of dapagliflozin 10mg daily within 24h of ED admission
Telephone follow-up by cardiac nurse practitioner at 1 monthOther
Telephone follow-up by cardiac nurse practitioner at 1 month
Standard acute decompensated heart failure careOther
Standard acute decompensated heart failure care
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | * Early initiation of dapagliflozin 10mg daily within 24h of ED admission
* Telephone follow-up by cardiac nurse practitioner at 1 month
* Standard acute decompensated heart failure care Receives: Drug: Early initiation of dapagliflozin 10mg daily within 24h of emergency department admission; Other: Telephone follow-up by cardiac nurse practitioner at 1 month; Other: Standard acute decompensated heart failure care |
| Control group | Active comparator | ✓ Standard acute decompensated heart failure care ONLY Receives: Other: Standard acute decompensated heart failure care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organizational feasibility: Implementation of procedures
Successful implementation of study procedures (yes/no). Binary assessment of whether study procedures were successfully implemented at each site.
Measured: 3 months
Organizational feasibility: Patient flow assessment
Proportion of eligible patients successfully enrolled. Ratio of patients enrolled to patients screened, expressed as percentage.
Measured: 3 months
Acceptability: Number of refusals
Number of patients refusing participation. Total count of eligible patients who declined to participate.
Measured: 3 months
Acceptability: Reasons for refusal
Categories of refusal reasons. Qualitative categorization of stated reasons for study refusal.
Measured: 3 months
Protocol adherence: Attrition rate
Proportion of participants completing the study protocol. Percentage of enrolled patients who complete all protocol requirements without withdrawal.
Measured: 3 months
Protocol adherence: CRF completion rate
Case report form completion rate. Percentage of required case report form fields completed across all participants.
Measured: 3 months
Protocol adherence: Telephone follow-up success rate
Proportion of patients successfully contacted by telephone at 1 month. Percentage of intervention group patients successfully reached for telephone follow-up by cardiac nurse practitioner.
Measured: 1 month
Timeline adherence
Study timeline compliance (yes/no). Binary assessment of whether study met anticipated timeline for recruitment and follow-up phases.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatimata SARR, PhD, Study chair, CHU BesançonFrédéric MAUNY, MD, PhD, Study chair, CHU BesançonMarc PUYRAVEAU, MSc, Study chair, CHU BesançonThibaut DESMETTRE, MD, PhD, Study chair, University Hospital, GenevaJohan COSSUS, MD, Study chair, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392788
- Sponsor's protocol ID
- 2024/882
- Acronym
- GlifloFastER
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan Description: De-identified individual participant data (IPD) that underlie the results reported in published articles, including the study protocol, statistical analysis plan, and informed consent form, may be shared upon reasonable request after study completion and primary publication. Access Criteria:
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Gliflozin Treatment in Elderly Patient Hospitalized for Decompensated Chronic Heart Failure Admitted in the Emergency Room - a Feasibility Study
- ClinicalTrials.gov ID
- NCT07392788
- Acronym / sponsor ID
- GlifloFastER / 2024/882
- Conditions
- Acute Heart Failure (AHF)
- Keywords
- acute heart failure, emergency department, elderly, SGLT2 Inhibitors, Feasibility study, Acute Decompensated Chronic Heart Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Early initiation of dapagliflozin 10mg daily within 24h of emergency department admission, Other: Telephone follow-up by cardiac nurse practitioner at 1 month, Other: Standard acute decompensated heart failure care* Early initiation of dapagliflozin 10mg daily within 24h of ED admission * Telephone follow-up by cardiac nurse practitioner at 1 month * Standard acute decompensated heart failure care |
| Control group | Active comparator | Other: Standard acute decompensated heart failure care✓ Standard acute decompensated heart failure care ONLY |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Age ≥ 75 years
- ED admission for ADCHF with:
- Expected hospitalization
- No prior gliflozin treatment
- Signed informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early initiation of dapagliflozin 10mg daily within 24h of emergency department admissionEarly initiation of dapagliflozin 10mg daily within 24h of ED admission | Drug | Intervention group |
| Telephone follow-up by cardiac nurse practitioner at 1 monthTelephone follow-up by cardiac nurse practitioner at 1 month | Other | Intervention group |
| Standard acute decompensated heart failure careStandard acute decompensated heart failure care | Other | Control group, Intervention group |
Primary outcome
Organizational feasibility: Implementation of procedures
Time frame: 3 months
Successful implementation of study procedures (yes/no). Binary assessment of whether study procedures were successfully implemented at each site.
Organizational feasibility: Patient flow assessment
Time frame: 3 months
Proportion of eligible patients successfully enrolled. Ratio of patients enrolled to patients screened, expressed as percentage.
Acceptability: Number of refusals
Time frame: 3 months
Number of patients refusing participation. Total count of eligible patients who declined to participate.
Acceptability: Reasons for refusal
Time frame: 3 months
Categories of refusal reasons. Qualitative categorization of stated reasons for study refusal.
Protocol adherence: Attrition rate
Time frame: 3 months
Proportion of participants completing the study protocol. Percentage of enrolled patients who complete all protocol requirements without withdrawal.
Protocol adherence: CRF completion rate
Time frame: 3 months
Case report form completion rate. Percentage of required case report form fields completed across all participants.
Protocol adherence: Telephone follow-up success rate
Time frame: 1 month
Proportion of patients successfully contacted by telephone at 1 month. Percentage of intervention group patients successfully reached for telephone follow-up by cardiac nurse practitioner.
Timeline adherence
Time frame: 3 months
Study timeline compliance (yes/no). Binary assessment of whether study met anticipated timeline for recruitment and follow-up phases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Yes. Plan Description: De-identified individual participant data (IPD) that underlie the results reported in published articles, including the study protocol, statistical analysis plan, and informed consent form, may be shared upon reasonable request after study completion and primary publication. Access Criteria:
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-France SERONDE, MD, PhD contact
Fatimata SARR, PhD study chair
CHU Besançon
Frédéric MAUNY, MD, PhD study chair
CHU Besançon
Marc PUYRAVEAU, MSc study chair
CHU Besançon
Questions about this trial
What is this clinical trial studying?
A study testing Early initiation of dapagliflozin 10mg daily within 24h of emergency department admission, Telephone follow-up by cardiac nurse practitioner at 1 month and Standard acute decompensated heart failure care in people with Acute Heart Failure (AHF), run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omide TAHERI, MD, PhD (03 81 66 70 28, omide.taheri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organizational feasibility: Implementation of procedures (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.