dapagliflozin propanediol monohydrate for Chronic decompensated heart failure

Inclusion criteria

• {"criterion_text":"- Male or female, age ≥ 75 years\n- Admitted to the emergency department for acute decompensated heart failure, diagnosed by the emergency physician based on a range of factors including: (i) Worsening symptoms of chronic heart failure - worsening dyspnea or dyspnea at rest - progressive asthenia -\tweight gain - worsening of edema/abdominal distension/anasarca (ii) AND objective signs or diagnostic tests consistent with peripheral and/or pulmonary congestion - jugular venous distension - bilateral crackles on pulmonary auscultation - presence of S3 gallop on cardiac auscultation - ascites - hepatomegaly - peripheral edema - radiological and/or ultrasound signs of pulmonary congestion - dilatation of the inferior vena cava (iii) AND elevated natriuretic peptides (BNP or NT-proBNP): a. For patients in sinus rhythm: BNP ≥ 400 pg/mL or NT-proBNP ≥ 1,600 pg/mL b.\tFor patients with atrial fibrillation: BNP ≥ 600 pg/mL or NT-proBNP ≥ 2,400 pg/mL) (iv) AND need for treatment intensification upon admission (increased doses of oral diuretics, addition of a second diuretic, or initiation of intravenous diuretic therapy);\n- Patients considered for hospitalization;\n- No pre-existing treatment with gliflozins (empagliflozin or dapagliflozin);\n- Signed and dated informed consent"}

Exclusion criteria

• {"criterion_text":"- Type 1 diabetes,\n- Chronic kidney disease (glomerular filtration rate < 25 ml/min/1.73 m²),\n- Cardiogenic shock,\n- Presence of acute coronary syndrome on ECG or within 30 days prior to randomization,\n- Any severe valvular heart disease that may require surgery during the study.\n- Percutaneous or surgical coronary intervention planned or performed within 30 days prior to randomization,\n- Known intolerance or history of hypersensitivity to the active substance or any of the excipients in the medication\n- Persons deprived of liberty,\n- Persons subject to legal protection measures, psychiatric care, persons admitted to a health or social care facility,\n- Individuals unable to express consent, follow instructions, or comply with follow-up procedures,\n- Any other medical condition that would put the patient at risk or could influence the results of the study,\n- Not affiliated with or not a beneficiary of a French social security system,\n- Subject is in the exclusion period of another study or listed in the “national volunteer registry.”,\n- The patient is finally referred and admitted to the Cardiology Department.,\n- The patient is ultimately referred to return home or to a residential care facility for dependent elderly people."}

Primary endpoints

• {"endpoint_text":"- Organizational feasibility: setting up procedures, distribution of subjects in the flow chart. Acceptability based on refusal characteristics: number and reason. Adherence to the protocol and treatment: attrition, completeness of emergency CRF and IPA completion, proportion of patients contacted by telephone, compliance with the treatment and follow-up regimen. Compliance with the provisional timeline for the implementation of the study","definition_or_measurement_approach":"Measured by number and reasons for refusals (acceptability), distribution of subjects in the study flow chart, attrition rates, completeness of emergency CRF and IPA completion, proportion of patients contacted by telephone, compliance with prescribed treatment and follow-up regimen, and adherence to the provisional implementation timeline."}

Secondary endpoints

• {"endpoint_text":"- A composite endpoint comprising the following at 3 months: - All-cause mortality - Rehospitalization or unplanned visit for CHF - Deterioration in quality of life: 5-point decrease after 3 months of treatment compared to the value measured at hospital discharge (KCCQ-12)\n- Each of the three criteria of the composite criterion taken individually\n- A 50% decrease in NT-proBNP levels at 7 days (or upon discharge from hospital if earlier than 7 days) and at 3 months\n- Regression of clinical signs (dyspnea, asthenia, congestive signs) at 7 days (or upon discharge from hospital if earlier than 7 days) and at 3 months\n- Tolerance in relation to renal function: difference between glomerular filtration rate relative to baseline (at randomization) at 7 days (or at hospital discharge if earlier than 7 days) and at 3 months.","definition_or_measurement_approach":"Composite and individual clinical outcomes assessed at 3 months: all-cause mortality and rehospitalization/unplanned CHF visits recorded as events; QoL measured by KCCQ-12 with deterioration defined as a 5-point decrease from discharge value. NT-proBNP measured at 7 days/discharge and 3 months; endpoint defined as 50% decrease vs baseline. Clinical sign regression assessed at 7 days/discharge and 3 months. Renal tolerance assessed by change in glomerular filtration rate vs baseline at 7 days/discharge and 3 months."}

Methods

• Identification and enrolment of eligible elderly patients (age ≥75) admitted to participating emergency departments in France for acute decompensated chronic heart failure (site-based recruitment in participating hospitals' emergency departments).

France

Earliest CTIS Part Ii Submission Date

23-02-2026

Latest Decision Or Authorization Date

31-03-2026

Processing Time Days

36

Number Of Sites

7

Number Of Participants

144

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France