Efficacy and Safety of Early Initiation of Canagliflozin in Patients With Acute Decompansted Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- The cumulative mean of daily diuresis
研究概览
简要总结
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.V loop diuretic during the hospitalization period.
详细描述
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 included in the study will continue on canagliflozin for 3 months after hospital discharge to evaluate the incidence of re-hospitalization, mortality rate and other benefits related to HF symptoms will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Group A(Intervention group)
patients will receive 100 mg canagliflozin initiated within 24 hours from patients hospital admission due to signs of hypervolemic state. All patients also will be prescribed the conventional diuretic therapy and other medications such as angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), beta-blockers, angiotensin receptor-neprilysin inhibitor (ARNI) and mineralocorticoid receptor antagonists (MRAs). Canagliflozin will be continued for 90 days after hospital discharge
干预措施: Canagliflozin (Drug)
Group B
patients will receive 10 mg Empagliflozin initiated within 24 hours from patients hospital admission due to signs of a hypervolemic state.All patients also will be prescribed conventional diuretic therapy and other medications including ACEIs, ARBs, beta-blockers, ARNI, and MRAs.Empagliflozin will be continued for 90 days after hospital discharge
干预措施: Empagliflozin (Drug)
结局指标
主要结局
The cumulative mean of daily diuresis
时间窗: After (day1)24 hours from hospital admission and until Day 5 or discharge if earlier
which is define as total urine output in 24 hours during the hospitalization period.
次要结局
- Incidence of ketoacidosis(Baseline to 90 days post discharge)
- Serum potassium(Baseline to hospital discharge, an average of 5-6 days.)
- Measuring diuretic response(Baseline to hospital discharge, an average of 5-6 days)
- Presence of symptoms of congestion and dyspnea at discharge(Baseline to hospital discharge, an average of 5-6 days.)
- The incidence of worsening of heart failure case(Baseline to hospital discharge, an average of 5-6 days.)
- Fractional Excretion of Sodium (FENa)-based diuretic efficiency(Baseline to hospital discharge, an average of 5-6 days.)
- Serum glucose covariate adjusted for baseline with attention to both elevation(Baseline to hospital discharge, an average of 5-6 days.)
- The change in the level of NT-pro BNP(Baseline to hospital discharge, an average of 5-6 days)
- Intensive care unit (ICU) length of stay(Baseline to hospital discharge, an average of 5-6 days)
- Incidence of symptomatic, sustained hypovolemic hypotension(Baseline to hospital discharge, an average of 5-6 days.)
- In-hospital mortality(Baseline to hospital discharge, an average of 5-6 days.)
- Hospital readmission within 90 days of discharge for heart failure(within 90 post discharge)
- Incidence of mortality within 90 days from discharge due cardiovascular cause(within 90 post discharge)
- The progression of heart failure severity(within 90 post discharge)
- The incidence of worsening of renal function(Baseline to 90 post discharge)
- Any reported adverse events during follow up period.(within 90 post discharge)
研究者
rabab ahmed mohamed
Assistant lecturer ,MSc
October 6 University