Evaluation of Blood Volume Analysis- Guided Management of Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Quantitative assessment of progress to euvolemic target for both subjects and controls
研究概览
简要总结
Diuretic therapy is first-line treatment for acute decompensated heart failure. However, accurate assessment and management of patient blood volume is challenged by the limitations of physical exam and surrogate markers for blood volume. The study primary objective is to determine if goal-directed care as quantified by direct Blood Volume Analysis (Daxor BVA-100™) in addition to usual care results in more appropriate treatment and consistent achievement of euvolemia.
详细描述
Over 6 million Americans suffer from heart failure, one of the most prevalent and deadly diseases in the United States. High rates of rehospitalization and mortality and treatment costs have persisted for decades despite advances in care. Clinical guidelines recommend assessment of blood volume and clinical management to euvolemia or normal blood volume, but standard methods of diagnosing blood volume status have been shown to be unreliable. Blood Volume Analysis (Daxor BVA-100) is based on the gold standard indicator dilution technique. BVA has been used to quantify otherwise undiagnosed blood volume derangements and guide treatment in heart failure and other indications. Also, retrospective analyses have shown that care of heart failure patients guided by BVA is associated with improved rates of rehospitalization and mortality.
The proposed study is a prospective, two-center, parallel design, interventional, single-blinded pilot study of the potential for BVA to positively impact the treatment decisions of ADHF clinicians.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants and treating physicians will have no access to the BVA data in the Standard Care arm.
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. In accordance with the Inclusion Across the Lifespan policy, Children will be excluded from the proposed study. ADHF is a condition that rarely affects children and Daxor's BVA-100 lack the reference norms for pediatric use.
- •Admission to the hospital with a primary diagnosis of ADHF.
- •Able and willing to provide informed written consent.
排除标准
- •Evidence of acute coronary syndrome or myocardial infarction during qualifying ADHF hospitalization.
- •Evidence of hypertensive crisis or acute valvular regurgitation.
- •The following has occurred within the last 3 months or is planned within the following 3 months:
- •Revascularization procedure.
- •Placement on cardiac transplantation list.
- •Other major cardiac surgery or other surgery.
- •Planned intermittent or continuous intravenous positive inotropic therapy.
- •Severe chronic kidney disease (eGFR<15 ml/min).
- •Psycho-social factors that interfere with ability to adhere to study procedures (severe dementia, active substance abuse, poorly controlled psychiatric illnesses).
- •Pregnant women or nursing mothers.
- •Women of childbearing potential not using adequate birth control methods.
- •Known hypersensitivity to iodine or eggs.
- •Participation in another heart failure investigational treatment protocol currently or <30 days prior to enrollment.
- •Evidence of active bleeding or active hemolysis.
- •Hemoglobin measured below 7 g/dl or hematocrit measured below 21%.
- •Patient has received a heart transplant and/or currently treated with mechanical circulatory support.
- •Patients implanted with invasive hemodynamic monitors (i.e. CardioMEMS).
结局指标
主要结局
Quantitative assessment of progress to euvolemic target for both subjects and controls
时间窗: Approximately 2 weeks
Accurately quantify levels and changes to blood volume and red blood cell volume in ADHF inpatients during inpatient stay, and use this data to guide diuretic therapy in the treatment arm.
次要结局
- Quantitative assessment of event-based outcome metrics(30 days post discharge)
- Quantitative assessment of continuous outcome metrics: weight(Approximately 2 weeks)
- Quantitative assessment of continuous outcome metrics: natriuretic peptide(Approximately 2 weeks)
- Quantitative assessment of continuous outcome metrics: net fluid balance(Approximately 2 weeks)