Tolvaptan for the Management of Acute Decompensated Heart Failure in Patients With Advanced or Refractory Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
This study will clarify the clinical usefulness of Tolvaptan therapy in patients with complicated acute decompensated heart failure and hyponatremia (low blood sodium).
详细描述
Despite its demonstrated efficacy and tolerability, Tolvaptan remains underutilized for the treatment of acute decompensated heart failure (ADHF) in many centers. Post-hoc analysis suggests that Tolvaptan may provide optimal outcomes in patients with more advanced heart failure (HF) including those with cardiorenal syndrome, marked hyponatremia and severe congestion, or a combination of those conditions. The efficacy of Tolvaptan in HF patients with loop diuretic resistance and in those requiring inotropic support remains uncertain.
The purpose of this study is to examine the benefit of Tolvaptan versus the current standard of care diuretic therapy for patients hospitalized with ADHF and evidence of advanced or complex HF with severe hyponatremia. Patients with advanced or complex disease are defined as those with suboptimal diuretic response over a 48 hour period.
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
- •Hospital admission for ADHF with volume overload as evidenced by ≥ 2 of the following: Elevated JVP, peripheral edema, ascites, pulmonary rales, congestion on chest X-ray, elevated NT-pro-BNP > 2000 pg/ml
- •Inadequate clinical response indicated by body weight loss < 1.0 kg/day over 48 hours despite adequate doses of IV loop diuretic (at least 40 mg furosemide daily) and fluid restriction 2 L/24 hours.
- •≥1 of the following over the preceding 48 hours: Potential need for inotropic support to improve urine output, and/or renal insufficiency (estimated glomerular filtration rate <45 mL/min/1.73 m2)
- •Serum sodium ≤134 mmol/L
- •≥18 years-old
排除标准
- •Cardiac surgery within 60 days of enrollment
- •Planned cardiac mechanical support or transplant; subjects with previously implanted ventricular assist device (VAD) will not be excluded
- •Need for intravenous pressor support for symptomatic hypotension
- •Biventricular pacemaker placement within the last 60 days
- •Hemofiltration or dialysis
- •Known cirrhosis
- •Supine systolic arterial blood pressure less than 85 mmHg
- •Refusal or inability to sign informed consent
研究组 & 干预措施
Tolvaptan
Tolvaptan 15-60 mg, once daily for 4 days or until hospital discharge
干预措施: Tolvaptan (Drug)
Standard of care diuretic therapy
Usual standard of care diuretic therapy for patients with acute decompensated heart failure
干预措施: Standard of care diuretic therapy (Drug)
结局指标
主要结局
Change in body weight
时间窗: From randomization to 96 hours after randomization
次要结局
- Need for intensive care unit admission(From hospital admission to 30 days post randomization)
- Total 96 hour urine output(From randomization to 96 hours post randomization)
- Proportion of patients developing worsening renal function (WRF)(From randomization to 7 days post randomization)
- Length of hospitalization(From hospital admission to 30 days post randomization)
- Need for positive inotropic agent use(From randomization to 7 days post randomization)
- Composite of Worsening Renal Function or need for inotropic agent(From randomization to 7 days post randomization)
- 30 day cardiovascular death and/or hospitalization(From Randomization to 30 days post randomization)
- Clinical markers of congestion(From randomization to 96 hours after randomization)
- Subjective change in shortness of breath(48 hours after randomization and 96 hours post randomization)
- Change in renal function(From randomization to 7 days post randomization)
- Change in serum sodium(From randomization to 7 days post randomization)
- Change in N-terminal brain natriuretic peptide (NT-pro BNP)(From randomization to 96 hours post randomization compared to baseline)
研究者
Dr. Jonathan Howlett
Clinical Professor
University of Calgary