Strategies for Tailoring Advanced Heart Failure Regimens in the Outpatient Setting: Brain Natriuretic Peptide Levels Versus the Clinical Congestion Score
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 135
- 主要终点
- Number of days neither hospitalized nor dead from the date of the first clinic visit to 90 days thereafter
研究概览
简要总结
The primary hypothesis is that, in patients with advanced heart failure, an outpatient fluid management strategy guided by BNP levels and clinical targets will lead to fewer days hospitalized or dead over a 3-month period compared to an outpatient fluid management strategy using clinical targets alone.
详细描述
STARBRITE will test the hypothesis that a defined fluid management strategy, tailored to specific symptoms and physiological targets, will improve morbidity and mortality in the advanced heart failure population. Individual targets for each patient will be based on the outcome of the index hospitalization, during which therapy is adjusted to optimize clinical status, blood pressure, and renal function. Identifying a standard fluid management strategy may be an important way to limit the complications of diuretic therapy and the duration of hospitalization for these patients. In addition, a standard approach may provide objective criteria that can be used to systematically deliver care in many types of clinical settings.
In this study, patients will be randomized to two strategies of outpatient fluid management: 1) the Congestion Score Strategy and, 2) the BNP Strategy.
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
- Single
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
- •Patients admitted with NYHA class III/IV symptoms of heart failure
- •Left ventricular ejection fraction ≤35%
- •Will have received at least one dose of intravenous diuretics during the current hospitalization
- •Prior to discharge, has received heart failure education and has learned about daily weights, and fluid, sodium, and dietary restrictions
- •Able to return for follow-up care at the Brigham and Women's Hospital Cardiomyopathy Clinic or the Duke Heart Failure Management Program
- •Has regular access to a telephone
- •≥18 years of age
排除标准
- •Moderate to severe valvular stenosis
- •Admitted with acute coronary syndrome
- •Creatinine >3.5
- •Renal failure on hemodialysis
- •Pregnant or lactating
结局指标
主要结局
Number of days neither hospitalized nor dead from the date of the first clinic visit to 90 days thereafter
时间窗: 90 day follow up
次要结局
- 1. Number of days not dead from the date of the first clinic visit to 90 days thereafter 2.Number of days not hospitalized from the date of the first clinic visit to 90 days thereafter(90 day follow up)