SANDI STUDY: Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in natriuresis 24 hours after acetazolamide
研究概览
简要总结
The goal of this observational study is to assess the natriuretic effect of intravenous acetazolamide in patients admitted with heart failure and persistent congestion despite treatment with intravenous furosemide and sodium-glucose cotransporter type 2 (iSGLT2) inhibitors.
The main question it aims to answer is whether there is a difference in natriuresis 24 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2).
详细描述
The SANDY study is a prospective, multicenter, observational study that will be conducted across 11 hospitals in Spain. It will enroll patients hospitalized for AHF presenting with clinical evidence of fluid overload. The study will evaluate natriuresis at 24 and 48 hours following intravenous acetazolamide administration in patients with persistent congestion despite treatment with intravenous furosemide and an SGLT2i. Upon admission, all patients will receive intravenous loop diuretics according to current European guideline recommendations. For those not previously treated with an SGLT2i, therapy will be initiated within the first 24 hours. Congestion will be reassessed 24 hours after combined loop diuretic and SGLT2i therapy. In line with the ADVOR trial, patients with persistent congestion (ADVOR score > 1) will receive intravenous acetazolamide (500 mg once daily) for up to two consecutive days.
During hospitalization and follow-up, participants will be encouraged to limit their daily dietary sodium and fluid intake to 3 g and 1500 ml, respectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted for acute heart failure and ≥ 1 clinical sign of volume overload (edema, ascites, or pleural effusion).
- •NTproBNP levels >1000 pg/mL or BNP >250 ng/mL on admission.
- •Under treatment with furosemide and iSGLT2 according to European guidelines and indication of association of another diuretic due to residual congestion data defined by ADVOR SCORE>1.
排除标准
- •Systolic blood pressure <90 mmHg or mean arterial pressure < 65 mmHg.
- •Maintenance treatment with acetazolamide/ Treatment with acetazolamide in the month prior to inclusion in the study.
- •Anticipated need for intravenous inotropes, vasopressors or nitroprusside during the study.
- •Contraindication to ISGLT
- •Type 1 diabetes mellitus
- •GFR < 20 ml/min/m2 or renal replacement therapy/ultrafiltration at any time prior to the study.
- •Anticipated exposure to nephrotoxic agents, such as iodinated contrast during admission.
- •Concurrent diagnosis of acute coronary syndrome.
- •History of congenital heart disease requiring surgical correction.
- •History of cardiac transplantation and/or ventricular assist device.
- •Pregnant or breastfeeding patients.
- •Inability to adequately collect diuresis.
- •Serum potassium less than 3.5 mEq/L.
- •Venous pH <7.30
- •Severe aortic stenosis or obstructive hypertrophic cardiomyopathy.
- •Sulfonamide allergy, liver cirrhosis, renal lithiasis.
研究组 & 干预措施
Hospitalized heart failure patients
Patients hospitalized with decompensated heart failure and fluid overload who require diuretic treatment for relieve of congestion. Standarized diuretic protocol according to guidelines will be applied, including loop diuretic and sodium-glucose cotransporter-2 inhibitors (SGLT2i)
干预措施: Acetazolamide 500mg (Drug)
结局指标
主要结局
Change in natriuresis 24 hours after acetazolamide
时间窗: 24 hours
Change in natriuresis (mmol) 24 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2).
次要结局
- Difference in ultrasound measurement of Inferior Vena Cava 48 hours after acetazolamide administration.(48 hours)
- Increase in diuresis 24 hours after acetazolamide administration(24 hours)
- Weight difference 24 hours after acetazolamide administration(24 hours)
- Difference in congestion score 24 hours after acetazolamide administration.(24 hours)
- Difference in ultrasound measurement of Inferior Vena Cava 24 hours after acetazolamide administration.(24 hours)
- Change in natriuresis 48 hours after acetazolamide administration(48 hours)
- Change in diuresis 48 hours after acetazolamide administration(48 hours)
- Weight difference 48 hours after acetazolamide administration(48 hours)
- Difference in congestion score 48 hours after acetazolamide administration.(48 hours)
- Change in Vexus score 24 hours after acetazolamide administration.(24 h post acetazolamide administration)
研究者
Julia Gonzalez
Cardiologist
Puerta de Hierro University Hospital