Feasibility of Early Dapagliflozin Initiation Versus Standard Care in Elderly Patients Hospitalized for Decompensated Chronic Heart Failure: A Randomized Study

The primary objective is to assess the feasibility of a prospective randomized study evaluating the early initiation of gliflozin treatment combined with telephone counseling in the emergency department compared to standard care. This investigation focuses on elderly patients hospitalized for decompensated chronic heart failure who are not currently receiving gliflozin therapy. The secondary objective is to:

• Quantify the potential efficacy and possible side effects associated with early initiation of treatment and telephone follow-up in the emergency department versus standard management.

The sponsor did not provide information regarding the total number of participants. The study population consists of male and female patients aged 75 years or older admitted to the emergency department for chronic decompensated heart failure. Eligible individuals must present with clinical symptoms such as worsening dyspnea, progressive asthenia, or edema, accompanied by objective signs of congestion or elevated natriuretic peptides. Participants must require treatment intensification upon admission and be considered for hospitalization. Individuals currently receiving treatment with gliflozins are excluded from the study.

This feasibility study is designed as a prospective randomized trial to evaluate the early initiation of gliflozin treatment combined with telephone counseling compared to standard care in elderly patients admitted to the emergency department for chronic decompensated heart failure. Eligible participants include individuals aged 75 years or older who present with acute decompensation characterized by clinical signs of congestion and elevated natriuretic peptides, such as BNP or NT-proBNP, and who have not previously received gliflozin therapy. The primary objective is to assess organizational feasibility, including protocol adherence, treatment compliance, and subject attrition. Secondary endpoints involve a composite measure of all-cause mortality, rehospitalization, and changes in quality of life at 3 months, as well as evaluations of renal function via glomerular filtration rate and reduction in clinical congestion signs. The study involves a screening process upon admission to the emergency department, followed by treatment implementation and monitoring. Follow-up assessments are conducted at 7 days, or upon hospital discharge, and at 3 months to evaluate clinical and biochemical responses. The estimated recruitment period for this study spans from March 2026 to August 2028.

The experimental medication consists of dapagliflozin propanediol monohydrate. This substance is administered via oral use at a dosage of 10 mg.

The control group receives standard care for patients hospitalized with decompensated chronic heart failure.

The primary assessment of organizational feasibility involves evaluating the establishment of procedures and subject distribution within the flowchart. Acceptability is determined by analyzing refusal characteristics, including the number and reasons for refusal. Protocol and treatment adherence are monitored through attrition rates, completeness of the emergency Case Report Form and Intent-to-Treat analysis, the proportion of patients contacted by telephone, and compliance with the treatment and follow-up regimen. Additionally, compliance with the provisional implementation timeline is evaluated.

Secondary efficacy endpoints include a composite endpoint measured at 3 months, comprising all-cause mortality, rehospitalization or unplanned visits for chronic heart failure, and a deterioration in quality of life, defined as a 5-point decrease in the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) compared to the value recorded at hospital discharge. Individual components of this composite criterion are also assessed.

Further secondary measures include the reduction of NT-proBNP levels, with a target of a 50% decrease at 7 days (or upon hospital discharge if earlier than 7 days) and at 3 months. The regression of clinical signs, specifically dyspnea, asthenia, and congestive signs, is assessed at 7 days (or upon hospital discharge) and at 3 months. Renal function tolerance is evaluated by measuring the difference in glomerular filtration rate relative to the baseline at randomization at 7 days (or upon hospital discharge) and at 3 months.