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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-naĂ¯ve, 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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
|
|
| Control group | Active Comparator | ✓ Standard acute decompensated heart failure care ONLY |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early initiation of dapagliflozin 10mg daily within 24h of emergency department admission | Drug | Early initiation of dapagliflozin 10mg daily within 24h of ED admission |
|
| Measure | Description | Time Frame |
|---|---|---|
| Organizational feasibility: Implementation of procedures | Successful implementation of study procedures (yes/no). Binary assessment of whether study procedures were successfully implemented at each site. | 3 months |
| Organizational feasibility: Patient flow assessment | Proportion of eligible patients successfully enrolled. Ratio of patients enrolled to patients screened, expressed as percentage. | 3 months |
| Acceptability: Number of refusals | Number of patients refusing participation. Total count of eligible patients who declined to participate. | 3 months |
| Acceptability: Reasons for refusal | Categories of refusal reasons. Qualitative categorization of stated reasons for study refusal. | 3 months |
| Protocol adherence: Attrition rate | Proportion of participants completing the study protocol. Percentage of enrolled patients who complete all protocol requirements without withdrawal. | 3 months |
| Protocol adherence: CRF completion rate | Case report form completion rate. Percentage of required case report form fields completed across all participants. | 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. |
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Inclusion Criteria:
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:
Need for treatment intensification
Expected hospitalization
No prior gliflozin treatment
Signed informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omide TAHERI, MD, PhD | Contact | 03 81 66 70 28 | omide.taheri@gmail.com | |
| Marie-France SERONDE, MD, PhD | Contact | marie-france.seronde2@univ-fcomte.fr |
| Name | Affiliation | Role |
|---|---|---|
| Fatimata SARR, PhD | CHU Besançon | Study Chair |
| Frédéric MAUNY, MD, PhD | CHU Besançon | Study Chair |
| Marc PUYRAVEAU, MSc |
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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:
After study completion and primary publication.
IPD may be available to researchers who provide a methodologically sound proposal for academic purposes. Requests should be directed to [principal investigator email]. Requestors will need to sign a data access agreement and obtain approval from their local ethics committee. Data will be shared in compliance with EU GDPR and French data protection regulations.
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| Telephone follow-up by cardiac nurse practitioner at 1 month | Other | Telephone follow-up by cardiac nurse practitioner at 1 month |
|
| Standard acute decompensated heart failure care | Other | Standard acute decompensated heart failure care |
|
| 1 month |
| Timeline adherence | Study timeline compliance (yes/no). Binary assessment of whether study met anticipated timeline for recruitment and follow-up phases. | 3 months |
| CHU Besançon |
| Study Chair |
| Thibaut DESMETTRE, MD, PhD | University Hospital, Geneva | Study Chair |
| Johan COSSUS, MD | CHU Besançon | Study Chair |
| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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