Early Gliflozin Treatment in Elderly Patient Hospitalized for Decompensated Chronic Heart Failure Admitted in the Emergency Room - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 144
- 主要终点
- Organizational feasibility: Implementation of procedures
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
Intervention group
- 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
干预措施: Early initiation of dapagliflozin 10mg daily within 24h of emergency department admission (Drug)
Intervention group
- 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
干预措施: Telephone follow-up by cardiac nurse practitioner at 1 month (Other)
Intervention group
- 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
干预措施: Standard acute decompensated heart failure care (Other)
Control group
✓ Standard acute decompensated heart failure care ONLY
干预措施: Standard acute decompensated heart failure care (Other)
结局指标
主要结局
Organizational feasibility: Implementation of procedures
时间窗: 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
时间窗: 3 months
Proportion of eligible patients successfully enrolled. Ratio of patients enrolled to patients screened, expressed as percentage.
Acceptability: Number of refusals
时间窗: 3 months
Number of patients refusing participation. Total count of eligible patients who declined to participate.
Acceptability: Reasons for refusal
时间窗: 3 months
Categories of refusal reasons. Qualitative categorization of stated reasons for study refusal.
Protocol adherence: Attrition rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 3 months
Study timeline compliance (yes/no). Binary assessment of whether study met anticipated timeline for recruitment and follow-up phases.
次要结局
未报告次要终点