Status:
COMPLETED
Canagliflozin in Patients With Acute Decompansted Heart Failure
Lead Sponsor:
October 6 University
Collaborating Sponsors:
Cairo University
National Heart Institute, Egypt
Conditions:
Chronic Heart Failure
Acute Heart Failure
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The study aims to investigate the efficacy and safety of the early initiation of canagliflozin treatment in hospitalized heart failure patients with volume overload (warm-wet) who require the use of I...
Detailed Description
The study will focus on the role of adding canagliflozin to I.V loop diuretic therapy early in unstable hospitalized acute heart failure patients regardless of diabetic state, patients who will be inc...
Eligibility Criteria
Inclusion
- Randomized within 24 of presentation during hospital admission for hypervolemic ADHF with evidence of congestion defined by the presence of any of the following signs or symptoms:
- Peripheral edema Ascites Jugular venous pressure \> 10 mmHg Orthopnea Paroxysmal nocturnal dyspnea 2.5 kg weight gain Signs of congestion on chest X-ray or lung ultrasound If pulmonary artery catheterization is available pulmonary capillary wedge pressure \> 19 mmHg plus a systemic physical examination finding of hypervolemia.
- Planned use of intravenous (IV) loop diuretic therapy during the current hospitalization Estimated glomerular filtration rate (e-GFR) \> 30 mL/min/1.73 m2 based on the Modification of Diet in Renal Disease (MDRD) equation.
Exclusion
- Type 1 diabetes Serum glucose \< 80 mg/dL Systolic blood pressure \< 90 mmHg Requirement of IV inotropic therapy History of hypersensitivity to any SGLT-2 inhibitors Already receiving therapy with an SGLT2 inhibitor Women who are pregnant or breastfeeding Severe anemia (Hemoglobin \< 7.5 g/dL)(24) Severe uncorrected aortic or mitral stenosis Inability to perform standing weights or measure urine output accurately Signs of ketoacidosis and/or hyperosmolar hyperglycaemic syndrome (pH \>7.3 and glucose \> 250 mg/dL and HCO3 \> 18 mmol/L) in diabetic patients at the time of inclusion to the study.
- The use of other diuretic therapies including; ≥100 mg/day spironolactone doses, ≥ 100 mg/day eplerenone, metolazone, hydrochlorothiazide, or other thiazides, systemic acetazolamide for the indication of diuretics, triamterene, or amiloride therapy.
- The use of other medications possessing natriuretic effect as nesiritide, or arginine vasopressin antagonists.
- Diffuse anasarca with 4+ edema and projected hypervolemia exceeding 18 kg. Severe hepatic impairment (Child-Pugh class C). Patients on hemodialysis Acute myocardial infarction with symptoms of acute ischemia or changes on electrocardiogram
Key Trial Info
Start Date :
June 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT05364190
Start Date
June 4 2022
End Date
March 1 2024
Last Update
July 11 2024
Active Locations (1)
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1
National heart institute
Giza, Egypt