Addition of Oral Metolazone to Intermittent Intravenous Furosemide Versus Transition to Continuous Infusion Furosemide in Acute Decompensated Heart Failure Patients Experiencing an Inadequate Response to Therapy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Daily Net Fluid Output on Day 2 (24-48 Hours After Randomization)
研究概览
简要总结
The purpose of this prospective, randomized, open-label study is to compare two diuretic strategies in patients with acute decompensated heart failure (ADHF): the addition of an oral thiazide diuretic to intravenous bolus (IVB) loop diuretic will be compared to transition from IVB to continuous infusion (CI) loop diuretic.
详细描述
Patients hospitalized for ADHF secondary to fluid overload and who are experiencing an inadequate response to IVB furosemide and require additional diuresis will be enrolled. Patients will be randomized to one of two treatment arms: the addition of oral metolazone to continued IVB furosemide versus transition from IVB to CI furosemide. A suggested algorithm for initial dosing and titration of these two diuretic strategies will be provided. Baseline and daily data collection will include various efficacy and safety endpoints including daily net urine output and weight, patient and physician global assessment scale, length of stay, 30-day death or rehospitalization, vital signs, electrolytes, and renal function. Clinically meaningful efficacy and safety endpoints will be compared.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than or equal to 18 years of age
- •Hospitalized for acute decompensated heart failure (ADHF) secondary to fluid overload as defined by the presence of at least
- •1 symptom (e.g. dyspnea, orthopnea, paroxysmal nocturnal dyspnea) AND
- •1 sign (e.g. rales on auscultation, > 2+ peripheral or presacral> edema, hepatomegaly, ascites, jugular vein distension > 7 cm, pulmonary vascular congestion on chest radiography)
- •Inadequate response to IV diuretics and requiring additional diuresis as determined by primary medical team
- •Received less than six doses of IV furosemide OR enrolled within 72 hours of hospital admission
- •Anticipated need for intravenous diuretic therapy for at least 48 hours
- •Able to provide informed consent
排除标准
- •Receiving a continuous infusion loop diuretic during current hospital visit
- •Substantial diuretic response to pre-randomization diuretic dosing such that higher doses of diuretic would be contraindicated (based on judgement of patient's primary team)
- •Planned or ongoing intravenous vasoactive therapy (e.g. inotrope, vasodilator) or mechanical support (e.g. intra-aortic balloon pump, ventricular assist device) for ADHF during this hospitalization
- •Planned elective admission for elective placement/revision of a cardiovascular device (e.g. defibrillator, biventricular pacemaker) during this hospitalization or such within the preceding 7 days
- •Systolic blood pressure < 90 mmHg
- •Serum creatinine > 3 mg/dL at baseline or renal replacement therapy including ultrafiltration
- •Serum potassium < 3.5 mEq/L (3.0 - 3.4 mEq/L allowed if supplemental potassium is being administered)
- •Serum magnesium < 1.6 mg/dL (1.4 - 1.5 mg/dL allowed if supplemental magnesium is being administered)
- •Acute coronary syndrome or hemodynamically significant arrhythmias causing worsening HF
- •Severe, uncorrected primary cardiac valvular disease, acute myocarditis, constrictive pericarditis, hypertrophic obstructive cardiomyopathy, restrictive or constrictive cardiomyopathy, complex congenital heart disease
- •Primary pulmonary hypertension with right sided heart failure
- •Use of iodinated radiocontrast material in prior 72 hours or planned within the next 48 hours
- •Enrollment or planned enrollment in another randomized clinical trial during hospitalization
研究组 & 干预措施
Addition of PO Thiazide Diuretic
Addition of oral metolazone 5 mg daily to current intravenous bolus furosemide. All subjects will continue their current dose of intravenous bolus furosemide.
干预措施: Addition of oral Metolazone (Drug)
IV furosemide dose escalation
Current IV furosemide dose will be escalated to 2-2.5 x current dose, given as either IV bolus or continuous infusion over 24 hours.
干预措施: Furosemide dose escalation (Drug)
结局指标
主要结局
Daily Net Fluid Output on Day 2 (24-48 Hours After Randomization)
时间窗: 24-48 hours
Net fluid output = fluid output during 24-48 hours after randomization - fluid intake during 24-48 hours after randomization. A negative value means that daily fluid intake was less than the daily fluid output.
次要结局
- Daily Net Fluid Output on Days 1, 3, and 4(0-24, 48-72, 72-96 hrs)
- Patient Global Assessment Scale(Baseline, 24, 48, 72, 96 hrs)
- Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received)(0-24, 24-48, 48-72, 72-96 hrs)
- Daily Weight(Baseline (Dry), Baseline, 0-24, 24-48, 48-72, 72-96 hrs)
- Physician Global Assessment Scale(Baseline, 24, 48, 72, 96 hours)
- Need for Additional or Alternative Diuretic (Crossover) or Other Vasoactive Therapy (Study Failure)(0-96 hours)
- Time to Return to Baseline Weight(0-96 hours)
- Length of Hospitalization(Assessed till hospital discharge, an average of 1 week (longest 29 days))
- 30-day All-cause Mortality(30 days)
- Rehospitalization at 30 Days(30 days)
- Unscheduled Heart Failure Visits to Emergency Department or Outpatient Clinic(30 days)
- Blood Urea Nitrogen (BUN)(Baseline, 24, 48, 72, 96 hours)