Acute Heart Failure (AHF)
Conditions
Keywords
acute heart failure, emergency department, elderly, SGLT2 Inhibitors, Feasibility study, Acute Decompensated Chronic Heart Failure
Brief 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. 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.
Interventions
DRUGEarly initiation of dapagliflozin 10mg daily within 24h of emergency department admission
Early initiation of dapagliflozin 10mg daily within 24h of ED admission
OTHERTelephone follow-up by cardiac nurse practitioner at 1 month
Telephone follow-up by cardiac nurse practitioner at 1 month
OTHERStandard acute decompensated heart failure care
Standard acute decompensated heart failure care
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 75 years 2. 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 * Atrial fibrillation: BNP ≥ 600 pg/mL or NT-proBNP ≥ 2,400 pg/mL * Need for treatment intensification 3. Expected hospitalization 4. No prior gliflozin treatment 5. Signed informed consent
Exclusion criteria
* 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 * Known intolerance to study medication * Legal protection measure or inability to consent * Hospitalization in cardiology department * Discharge home or to nursing home
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Organizational feasibility: Implementation of procedures | 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 | 3 months | Proportion of eligible patients successfully enrolled. Ratio of patients enrolled to patients screened, expressed as percentage. |
| Acceptability: Number of refusals | 3 months | Number of patients refusing participation. Total count of eligible patients who declined to participate. |
| Acceptability: Reasons for refusal | 3 months | Categories of refusal reasons. Qualitative categorization of stated reasons for study refusal. |
| Protocol adherence: Attrition rate | 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 | 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 | 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 | 3 months | Study timeline compliance (yes/no). Binary assessment of whether study met anticipated timeline for recruitment and follow-up phases. |
Contacts
CONTACTOmide TAHERI, MD, PhD
CONTACTMarie-France SERONDE, MD, PhD
STUDY_CHAIRFatimata SARR, PhD
CHU Besançon
STUDY_CHAIRFrédéric MAUNY, MD, PhD
CHU Besançon
STUDY_CHAIRMarc PUYRAVEAU, MSc
CHU Besançon
STUDY_CHAIRThibaut DESMETTRE, MD, PhD
University Hospital, Geneva
STUDY_CHAIRJohan COSSUS, MD
CHU Besançon
Outcome results
None listed