Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 894
- 试验地点
- 91
- 主要终点
- CV Death or Heart Failure Hospitalization
研究概览
简要总结
The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy compared with usual care in high risk patients with left ventricular systolic dysfunction.
详细描述
Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Common symptoms of heart failure include shortness of breath, swelling, and fatigue. Standard treatment for heart failure include diuretics to control fluid, as well as drugs called "neurohormonal antagonists" (such as beta-blockers and ACE-inhibitors) that help the heart work more efficiently and prevent worsening of heart function. Typically, doctors adjust these medicines based on their clinical judgment about what doses and combination will work best for you. We are testing whether the use of a blood test called NT-proBNP (which measures a hormone released by the heart) can help doctors do a better job of adjusting these heart failure medicines over time than clinical judgment alone.
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
- •Age 18 years or older
- •Most recent LVEF to be ≤ 40% by any method within 12 months of randomization.
- •High risk heart failure as defined by the following criteria:
- •A Heart Failure Event in the prior 12 months, defined as any one of the following:
- •HF Hospitalization
- •Treatment in the Emergency Department (or equivalent) for Heart Failure
- •Outpatient treatment for heart failure with intravenous diuretics
- •NT-proBNP greater than 2000 pg/mL or BNP greater than 400 pg/mL at any time during the 30 days prior to randomization
- •Willing to provide informed consent
排除标准
- •Acute coronary syndrome (clinical diagnosis) or cardiac revascularization procedure within 30 days
- •Cardiac resynchronization therapy (CRT) within prior 3 months or current plan to implant CRT device
- •Active myocarditis, Hypertrophic obstructive cardiomyopathy, pericarditis, or restrictive cardiomyopathy
- •Severe stenotic valvular disease
- •Anticipated heart transplantation or ventricular assist device within 12 months
- •Chronic inotropic therapy
- •Complex congenital heart disease
- •End stage renal disease with renal replacement therapy
- •Non cardiac terminal illness with expected survival less than 12 months
- •Women who are pregnant or planning to become pregnant
- •Inability to comply with planned study procedures
- •Enrollment or planned enrollment in another clinical trial
研究组 & 干预措施
Usual Care
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
干预措施: Usual Care (Other)
Biomarker-Guided Care
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
干预措施: Biomarker-guided care NT-proBNP (Device)
结局指标
主要结局
CV Death or Heart Failure Hospitalization
时间窗: 24 Months
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
次要结局
- Percentage of Patients With Moderate to Severe Depression(Baseline, 3,6, 12 and 24 months)
- Duke Activity Status Index (DASI)(Baseline, 3, 6, 12 and 24 months)
- EQ-5D Health Index(Baseline, 3, 6, 12 and 24 months)
- EQ-5D Visual Analog Scale(Baseline, 3, 6, 12 and 24 months)
- All-cause Mortality(24 months)
- Cumulative Morbidity(24 months)
- CV Death(24 months)
- Number of Hospitalizations for First Heart Failure(24 months)
- Number of Hospitalizations for Recurrent Heart Failure(24 months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score(Baseline, 3, 6,12 and 24 months)
- Short Form-36 (SF-36) General Health Subscale(Baseline, 3, 6, 12 and 24 months)
- Short Form-36 (SF-36) Mental Health Subscale(Baseline, 3, 6, 12 and 24 months)
- Short Form-36 (SF-36) Social Functioning Subscale(Baseline, 3, 6, 12 and 24 months)
- Short Form-36 (SF-36) Physiological Functioning Subscale(Baseline, 3, 6, 12 and 24 months)
- Short Form-36 (SF-36) Vitality Subscale(Baseline, 3, 6, 12 and 24 months)
- Resource Utilization(24 months)
- Resource Utilization Cost(24 months)