Effect of Adjuvant Dapagliflozin on Improving the Treatment of Congestion in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change in dyspnea ( Visual analogue scale) (VAS)
研究概览
简要总结
Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), increases natriuresis alone and synergistically when combined with loop diuretics in patients with AHF without increasing renin angiotensin- aldosterone activity. Thus, adding SGLT2i to the standard loop diuretic therapy might confer additional decongestive and natriuretic benefits while avoiding the adverse electrolyte abnormalities and neurohormonal activation associated with other diuretic combination. These potential benefits may help with improved clinical outcomes, but clinical evidence is still lacking.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older who are hospitalized for hypervolemic AHF, with evidence of congestion defined as either:
- •* 2 of the following signs or symptoms: peripheral edema, ascites, jugular venous pressure > 10mmHg, orthopnea, paroxysmal nocturnal dyspnea, 5-pound weight gain, or signs of congestion on chest x-ray or lung ultrasound.
- •*If pulmonary artery catheterization is available, a pulmonary capillary wedge pressure greater than 19 mmHg plus a systemic physical exam finding of hypervolemia from the list above.
- •Randomized within 24 hours of hospitalization for AHF
- •Planned use of IV loop diuretic therapy during current hospitalization
- •Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73m2 by the MDRD equation
- •For diabetic patients, history of type 2 diabetes or a new hemoglobin A1c 6.5% on admission.
排除标准
- •Type 1 diabetes mellitus.
- •Dyspnea primarily due to non-cardiac causes.
- •Cardiogenic shock.
- •Acute coronary syndrome within 30 days prior to randomization.
- •Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization.
- •Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH>7.30 and glucose >15 mmol/L and HCO3>18 mmol/L).
- •Pregnant or nursing (lactating) women.
- •Heart failure due to drug toxicity
- •Adherence to medication less than 95%
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
Dapagliflozine 10mg
干预措施: Dapagliflozin 10mg Tab (Drug)
结局指标
主要结局
Change in dyspnea ( Visual analogue scale) (VAS)
时间窗: From baseline to day 4
• Comparing the area under the curve (AUC) of change in VAS dyspnea score. To do so, individual changes in VAS score will be visualized as a curve where the x-axis shows study day baseline to day 5, and y-axis shows VAS score. the overall VAS AUC score (mm × h) will be compared across treatment groups
次要结局
- Incidence of worsening heart failure (HF)(From the date of randomization until discharge or end of treatment, whichever came first, assessed up to 30 days)
- All-cause death(60 days from discharge)
- Difference in serum levels of congestion biomarkers(4 days post-randomization)
- Hospital readmission(60 days from discharge)
- Urinary sodium 2 hours post randomization(2 Hours)
研究者
Noha Mansour
Lecturer of Clinical Pharmacy
Mansoura University