Early Gliflozin for Elderly Patients With Acute Decompensated Heart Failure in the Emergency Department

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Early initiation of dapagliflozin 10mg daily within 24h of emergency department admission
  Early initiation of dapagliflozin 10mg daily within 24h of ED admission
• Другое Telephone follow-up by cardiac nurse practitioner at 1 month
  Telephone follow-up by cardiac nurse practitioner at 1 month
• Другое Standard acute decompensated heart failure care
  Standard acute decompensated heart failure care

Первичные конечные точки

• Organizational feasibility: Implementation of procedures [Срок оценки: 3 months]
• Organizational feasibility: Patient flow assessment [Срок оценки: 3 months]
• Acceptability: Number of refusals [Срок оценки: 3 months]
• Acceptability: Reasons for refusal [Срок оценки: 3 months]
• Protocol adherence: Attrition rate [Срок оценки: 3 months]
• Protocol adherence: CRF completion rate [Срок оценки: 3 months]
• Protocol adherence: Telephone follow-up success rate [Срок оценки: 1 month]
• Timeline adherence [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

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Основная цель

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Центры проведения

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Идентификаторы

NCT: NCT07392788 · 2024/882

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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