Acute Heart Failure
Conditions
Keywords
Diabetic and non diabetic
Brief summary
Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), increases natriuresis alone and synergistically when combined with loop diuretics in patients with AHF without increasing renin angiotensin- aldosterone activity. Thus, adding SGLT2i to the standard loop diuretic therapy might confer additional decongestive and natriuretic benefits while avoiding the adverse electrolyte abnormalities and neurohormonal activation associated with other diuretic combination. These potential benefits may help with improved clinical outcomes, but clinical evidence is still lacking.
Interventions
DRUGDapagliflozin 10mg Tab
patients will receive once daily dapagliflozin 10 mg orally in addition to standard care
OTHERPlacebo
patients will receive placebo and standard care.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older who are hospitalized for hypervolemic AHF, with evidence of congestion defined as either: \* 2 of the following signs or symptoms: peripheral edema, ascites, jugular venous pressure \> 10mmHg, orthopnea, paroxysmal nocturnal dyspnea, 5-pound weight gain, or signs of congestion on chest x-ray or lung ultrasound. OR \*If pulmonary artery catheterization is available, a pulmonary capillary wedge pressure greater than 19 mmHg plus a systemic physical exam finding of hypervolemia from the list above. 2. Randomized within 24 hours of hospitalization for AHF 3. Planned use of IV loop diuretic therapy during current hospitalization 4. Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73m2 by the MDRD equation 5. For diabetic patients, history of type 2 diabetes or a new hemoglobin A1c 6.5% on admission.
Exclusion criteria
1. Type 1 diabetes mellitus. 2. Dyspnea primarily due to non-cardiac causes. 3. Cardiogenic shock. 4. Acute coronary syndrome within 30 days prior to randomization. 5. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization. 6. Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH\>7.30 and glucose \>15 mmol/L and HCO3\>18 mmol/L). 7. Pregnant or nursing (lactating) women. 8. Heart failure due to drug toxicity 9. Adherence to medication less than 95%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in dyspnea ( Visual analogue scale) (VAS) | From baseline to day 4 | • Comparing the area under the curve (AUC) of change in VAS dyspnea score. To do so, individual changes in VAS score will be visualized as a curve where the x-axis shows study day baseline to day 5, and y-axis shows VAS score. the overall VAS AUC score (mm × h) will be compared across treatment groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of worsening heart failure (HF) | From the date of randomization until discharge or end of treatment, whichever came first, assessed up to 30 days | Defined as worsening signs and/or symptoms of HF that require IV inotropic therapy or admission to an intensive care unit or mechanical ventilatory, renal or circulatory support. |
| All-cause death | 30 days from discharge | Difference in all cause mortality rate |
| Hospital readmission | 30 days from discharge | Difference between groups in rate of readmission after discharge for heart failure related reason |
| Urinary sodium 2 hours post randomization | 2 Hours | Difference in sodium execrated in urine (mmol/L) after 2 hours between study groups |
| Difference in serum levels of congestion biomarkers | 4 days post-randomization | Difference in serum levels of Nt-ProBNP 4 days post-randomization |
Countries
Egypt
Outcome results
None listed