Acute Decompensated Heart Failure
Conditions
Keywords
Empagliflozin, Acetazolamide, Metolazone, Acute heart failure, Add-on therapies to Loop diuretics
Brief summary
The aim of this study is to compare the efficacy and safety of empagliflozin, acetazolamide, and metolazone as add-on therapies to loop diuretics in patients with acute decompensated heart failure.
Interventions
DRUGempagliflozin
Empagliflozin may augment the natriuretic and aquaretic actions of loop diuretics in patients with acute decompensated heart failure and it does not typically cause electrolyte disturbances and has been shown to improve outcomes in patients with heart failure
DRUGAcetazolamide
Acetazolamide can augment the action of loop diuretics in patients with acute decompensated heart failure
DRUGmetolazone
Metolazone can augment the action of loop diuretics in patients with acute decompensated heart failure
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking Description
Intervention model description
Model Description
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients older than 18 years. 2. Hospital admission with clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload (e.g. edema, ascites confirmed by echography or pleural effusion confirmed by chest X-ray or echography).
Exclusion criteria
1. Type 1 diabetes. 2. Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<30 mL/min per 1.73 m² or end-stage kidney failure with the need for chronic dialysis treatment. 3. A systolic blood pressure of less than 90 mmHg. 4. Cardiogenic shock. 5. Receipt of acetazolamide maintenance therapy. 6. Receipt of an SGLT2 inhibitor, thiazide, or thiazide-like diuretic in the 48 hrs before randomization. 7. Any cause of heart failure leading to decompensation that will need urgent management (eg, acute coronary syndrome, unstable arrhythmias, acute pulmonary embolism). 8. Pregnant or breastfeeding women. 9. Moderate to severe anemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative urine output measured over 3 days | 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| - The change in serum level of N-terminal pro-brain natriuretic peptide (NT-proBNP) | 4 days | Blood samples will be collected at baseline and after 4 days |
| The change in serum level of Soluble suppression of tumorigenicity 2 (sST2) | 4 days | Blood samples will be collected at baseline and after 4 days |
| The change in urinary level of Tissue inhibitor of metalloproteinases-2 (TIMP-2 ) | 3 days | Urine samples will be collected at baseline and after 3 days |
| The change in urinary level of Insulin-like growth factor-binding protein 7 (IGFBP7) | 3 days | Urine samples will be collected at baseline and after 3 days |
| 30-day mortality | up to 30 days | Proportion of patients who die within 30 days of randomization |
| Proportion of patients achieving an ADVOR Score ≤ 1 without the need for escalating diuretic strategy | 3 days | the treating physician will calculate the congestion score, on a scale from 0 to 10 on the basis of the sum of scores for the degree of edema (0 to 4), pleural effusion (0 to 3), and ascites (0 to 3), with higher scores indicating a worse condition on all scales |
Countries
Egypt
Contacts
CONTACTDalia A Gomaa, MSc in clinical pharmacy
CONTACTDalia R El-Afify, Associate professor
PRINCIPAL_INVESTIGATORDalia A Gomaa, MSc in clinical pharmacy
Tanta University
Outcome results
None listed