DAPAGLIFLOZIN for Heart failure

Inclusion criteria

• {"criterion_text":"- Retrospective study All individuals with HF regardless of the left ventricular ejection fraction"}
• {"criterion_text":"- Prospective study"}
• {"criterion_text":"- 1.\tFemale patients >18 <85 years"}
• {"criterion_text":"- 2.\tHospital admission within the 24-48 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation."}
• {"criterion_text":"- 3.\tAll measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm."}
• {"criterion_text":"- 4.\tAll measures within 24 hours prior to Randomization of serum potassium ≤ 5.0 mEq/L (mmol/L)."}
• {"criterion_text":"- 5.\tBiomarker criteria for persistent congestion:"}
• {"criterion_text":"- 5.1.\tAt Screening, NT-proBNP >1,800 pg/mL (2,350 pg/mL in case of atrial fibrillation)"}
• {"criterion_text":"- 5.2.\tAt the time of Randomization (1-2 days prior to discharge), NT-proBNP >1,000 pg/mL (1,300 pg/mL in case of Atrial Fibrillation) to ensure the persistence of congestion and the acuity of the index episode)."}
• {"criterion_text":"- 6.\tAt 1 week prior to admission, at Screening, and at Visit 2"}
• {"criterion_text":"- 6.1.\tIf EF<50% (ie HFrEF or HFmrEF) either <½ the optimal dose of ACEi/ARB/ARNi and MRA and BB (see Table) must have been prescribed"}
• {"criterion_text":"- 6.2.\tIf EF>50% (ie HFpEF): <½ the optimal dose of MRA (see Table)"}
• {"criterion_text":"- 7.\tWritten informed consent to participate in the study."}

Exclusion criteria

• {"criterion_text":"- 1.\tMale patients"}
• {"criterion_text":"- 2.\tAge < 18 or > 85 years."}
• {"criterion_text":"- 3.\tMechanical ventilation (not including CPAP/BIPAP) in the 24 hours prior to Screening."}
• {"criterion_text":"- 4.\tSignificant pulmonary disease contributing substantially to the patients’ dyspnoea such as FEV1 <1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism."}
• {"criterion_text":"- 5.\tMyocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to Screening or during the index event."}
• {"criterion_text":"- 6.\tIndex Event (admission for AHF) triggered primarily by a correctable aetiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response >130 beats per minute, or bradycardia with sustained ventricular arrhythmia <45 beats per minute), infection, severe anaemia, acute coronary syndrome, pulmonary embolism, exacerbation of COPD, planned admission for device implantation or severe non-adherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not an exclusion."}
• {"criterion_text":"- 7.\tUncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy."}
• {"criterion_text":"- 8.\t History of heart transplant or on a transplant list or using or planned to be implanted with a ventricular assist device."}
• {"criterion_text":"- 9.\tSustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated."}
• {"criterion_text":"- 10.\tPresence at Screening of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation, or the presence of any hemodynamically significant obstructive lesion of the left ventricular outflow tract."}
• {"criterion_text":"- 11.\tActive infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated WBC or need for intravenous antibiotics."}
• {"criterion_text":"- 12.\tStroke or TIA within the 3 months prior to Screening."}
• {"criterion_text":"- 13.\tPrimary liver disease considered to be life threatening."}
• {"criterion_text":"- 14.\tRenal disease or eGFR < 30 mL/min/1.73m2 (as estimated by the simplified MDRD formula) at Screening or history of dialysis."}
• {"criterion_text":"- 15.\tPsychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy < 6 months."}
• {"criterion_text":"- 16.\tPrior (defined as less than 30 days from screening) or current enrollment in a CHF trial or participation in an investigational drug or device study within the 30 days prior to screening"}
• {"criterion_text":"- 17.\tDischarge for the AHF hospitalization anticipated to be >14 days from admission, or to a long-term care facility. Randomization must occur within 12 days following admission and at 1-2 days prior to anticipated discharge."}
• {"criterion_text":"- 18.\tInability to comply with all study requirements, due to major co-morbidities, social or financial issues or a history of noncompliance with medical regimens, that might compromise the patient’s ability to understand and/or comply with the protocol instructions or follow-up procedures"}
• {"criterion_text":"- 19.\tPregnant or nursing (lactating) women."}

Primary endpoints

• {"endpoint_text":"- Retrospective study: an up-to-date description of the “status quo” of the prescription of GDMT nationally and related inequality regarding sex in patients with HF based on analyses of National Registry data and Mecki Data-base.\n- Prospective study: •\tall-cause mortality within 1 year or HF readmission or worsening HF.","definition_or_measurement_approach":"Retrospective: descriptive analyses of national registry data and Mecki database. Prospective: endpoint measured as occurrence of all-cause mortality, HF readmission, or worsening HF within 1 year after randomisation (events captured during follow-up visits and medical records)."}

Secondary endpoints

• {"endpoint_text":"- Prospective study: a.the percentage of optimization of each single medical therapy (BB; ACEi, ARB or ARNi;and MRAs and SGLT2i)in women admitted with heart failure, b.effect of such intervention at 1 year:mortality;HF re-admission;worsening HF;quality of life (EQ-5D questionnaire). c.Other endpoints:include changes in biomarkers and changes in the primary and secondary endpoints in pre-determined subgroups including <50vs>50 EF;>vs<65 yr old,presence of diabetes,chronic kidney disease or obesity","definition_or_measurement_approach":"a. Optimization measured as percentage of patients achieving predefined target doses/therapy optimization for each drug class. b. Effect at 1 year measured as mortality, HF re-admission, worsening HF and QoL via EQ-5D at 12 months. c. Biomarker changes (e.g., NT-proBNP) and subgroup analyses by EF, age groups, diabetes, CKD, obesity."}

Italy

Earliest CTIS Part Ii Submission Date

16-10-2025

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

165

Number Of Sites

13

Number Of Participants

368

Primary sponsor

Full Name

Policlinico San Donato S.p.A.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy