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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin group | Active Comparator | will include 22 patients who will receive 10 mg oral empagliflozin administered simultaneously with the first dose of loop diuretics each day for 3 days |
|
| Acetazolamide group | Active Comparator | will include 22 patients who will receive 500 mg oral acetazolamide administered simultaneously with the first dose of loop diuretics each day for 3 days |
|
| Metolazone group | Active Comparator | will include 22 patients who will receive 5 mg oral metolazone administered simultaneously with the first dose of loop diuretics each day for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| empagliflozin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The cumulative urine output measured over 3 days | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| - The change in serum level of N-terminal pro-brain natriuretic peptide (NT-proBNP) | Blood samples will be collected at baseline and after 4 days | 4 days |
| The change in serum level of Soluble suppression of tumorigenicity 2 (sST2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dalia A Gomaa, MSc in clinical pharmacy | Contact | +20+01063410525 | dalia_gomaa@pharm.tanta.edu.eg | |
| Dalia R El-Afify, Associate professor | Contact | +20+01006831093 | dalia.mohamed1@pharm.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Dalia A Gomaa, MSc in clinical pharmacy | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta university | Recruiting | Tanta | Egypt |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D000086 | Acetazolamide |
| D008788 | Metolazone |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Model Description
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Masking Description
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|
| Acetazolamide | Drug | Acetazolamide can augment the action of loop diuretics in patients with acute decompensated heart failure |
|
| metolazone | Drug | Metolazone can augment the action of loop diuretics in patients with acute decompensated heart failure |
|
Blood samples will be collected at baseline and after 4 days
| 4 days |
| The change in urinary level of Tissue inhibitor of metalloproteinases-2 (TIMP-2 ) | Urine samples will be collected at baseline and after 3 days | 3 days |
| The change in urinary level of Insulin-like growth factor-binding protein 7 (IGFBP7) | Urine samples will be collected at baseline and after 3 days | 3 days |
| 30-day mortality | Proportion of patients who die within 30 days of randomization | up to 30 days |
| Proportion of patients achieving an ADVOR Score ≤ 1 without the need for escalating diuretic strategy | 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 | 3 days |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D052999 | Quinazolinones |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |