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the study to investigate the efficacy of empagiflozin in pediatric heart failure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Active Comparator | 30 patients will receive standard of care only which includes ACE inhibitors, ARBs, beta-blocker, mineralocorticoid receptor antagonist, and loop diuretics according to case demand. |
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| protocol | Experimental | 30 patients will receive empagliflozin for 90 days in addition to standard of care. empagliflozin will be administered at a starting dose 0.25-0.5 mg/kg/day (maximum 25 mg per day) enterally once daily using available 10mg and 25mg tablet for at least 30 days to patients already receiving standard HF medical therapy. Assess for glucosuria no sooner than one week after starting empagliflozin with target of 1+to 3+. If negative or trace glucosuria, increase dose to maintain target 0.25-0.5 mg/kg/day (maximum 25 mg once daily). for patients who cannot swallow tablet, tablet of 10mg will be crushed and mixed with 10 ml of water to make concentration of 1mg/1ml and calculated dose given from this solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin (EMPA) | Drug | It's a randomized open-label two-arm prospective parallel study of 60 pediatric hospitalized patients. experimental Group : 30 patients will receive empagliflozin for 90 days in addition to standard of care. empagliflozin will be administered at a starting dose 0.25-0.5 mg/kg/day (maximum 25 mg per day) enterally once daily using available 10mg and 25mg tablet for at least 30 days to patients already receiving standard HF medical therapy. Assess for glucosuria no sooner than one week after starting empagliflozin with target of 1+to 3+. If negative or trace glucosuria, increase dose to maintain target 0.25-0.5 mg/kg/day (maximum 25 mg once daily). active comparator Group : 30 patients will receive standard of care only which includes ACE inhibitors, ARBs, beta-blocker, mineralocorticoid receptor antagonist, and loop diuretics. |
| Measure | Description | Time Frame |
|---|---|---|
| serum Brain Natriuretic Peptide (BNP) in pg/mL | Day1 and on day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular ejection fraction (LVEF) measured by M-mode echocardiography | on Day1 and on day 90 | |
| and Global Longitudinal Strain (GLS) measured by speckle-tracking echocardiography | Day1 and on day 90 |
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Inclusion Criteria:
• Pediatrics (aged 1months-18 years)
HF will be defined by reduced ventricular systolic function (left ventricular ejection fraction by echocardiography) or impaired ventricular filling (pulmonary capillary wedge pressure > 18 mmHg measured directly and/or the ratio of early diastolic mitral inflow velocity(E) to early diastolic mitral annular velocity (e')( E/e'>14 by echocardiography) with clinical features of congestion and/or low cardiac output.
• Class III or IV of ROSS classification or BNP level more than 300 pg/mL
Exclusion Criteria:
• Pediatric with chronic kidney failure
Avoid initiating empagliflozin in patients with concurrent urinary tract infection (UTI).
patients with eGFR <60 mL/minute/1.73 m2 will be excluded.
Patients with contraindication to empagliflozin usage which include
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| nassar elsayed nassar, master candidate | Contact | +0021223333236 | nassar.mohamed17@pharma.asu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams Hospital | Recruiting | Cairo | Cairo Governorate | Egypt |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006332 | Cardiomegaly |
| D009202 | Cardiomyopathies |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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|
| Standard medical treatment | Drug | ACE inhibitors, ARBs, beta-blocker, mineralocorticoid receptor antagonist, and loop diuretics according to case demand. |
|
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |