A Prospective Study to Determine the Association of Quantitated Blood and Plasma (Intravascular) Volume to Right Heart Hemodynamics, Venous Capacitance, and Regulatory Neurohormones in Patients With Chronic Heart Failure of Reduced and Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total Blood Volume Measurement
研究概览
简要总结
The primary hypothesis is that patients with HFREF (heart failure with reduced ejection fraction) will demonstrate a markedly expanded intravascular volume which will correlate with elevated right heart hemodynamics and increased venous capacitance parameters, whereas patients with HFPEF(heart failure with preserved ejection fraction) will demonstrate euvolemia to mild volume expansion and a lack of correlation with hemodynamic and venous compliance parameters.
详细描述
The purpose of this study is to learn more about how the heart, blood vessels and blood volume interact in patients with heart failure and how measuring blood volume and vein capacity may help us develop better ways of treating and managing heart failure patients. This study will use two tests to measure blood volume and test the capacity of your veins and arteries in your limbs.
The blood volume test (also called a plasma volume test or a red cell mass test) is a standard clinical nuclear lab procedure used to measure the volume (amount) of blood in the body. The test also measures the volume of plasma and of red cells in the blood.
The other test is called a venous plethysmography, which is a non-invasive test to measure how well your veins and arteries in your forearm and calf work. Venous plethysmography measures the changes in the dimensions of your limbs by the use of strain gauges placed on the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •patients identified with heart failure and diagnosed clinically to require right heart hemodynamic evaluation, New York Heart Association functional Class II-IV status/Stage C-D heart failure
- •ischemic or nonischemic etiology heart failure
- •left ventricular ejection fraction measured within 6 months of study enrollment
排除标准
- •known significant intrinsic chronic kidney disease (baseline Glomerular Filtration Rate <15 ml/min/1.73m²) or patients receiving hemodialysis
- •known renal artery stenotic disease
- •females who are pregnant
- •allergy to iodine contrast, intravenous pyelogram dye, shellfish or eggs.
研究组 & 干预措施
Heart Failure Reduced EF
Patient prior to clinically ordered right heart catheterization identified patients will have a blood volume measurement completed in the nuclear medicine laboratory. Patients will receive an intravenous administration of low dose iodinated I-131 labeled albumin. Blood specimens (6 cc each) will be drawn at 6 minute intervals times 6. The analysis will be completed following the testing.
Venous plethysmography will be completed on eligible patients prior to the clinically indicated right heart catheterization. Calf and forearm venous compliance will be measured.
Measurements form the right heart catheterization will be recorded for analysis.
干预措施: blood volume measurement (Procedure)
Heart Failure Reduced EF
Patient prior to clinically ordered right heart catheterization identified patients will have a blood volume measurement completed in the nuclear medicine laboratory. Patients will receive an intravenous administration of low dose iodinated I-131 labeled albumin. Blood specimens (6 cc each) will be drawn at 6 minute intervals times 6. The analysis will be completed following the testing.
Venous plethysmography will be completed on eligible patients prior to the clinically indicated right heart catheterization. Calf and forearm venous compliance will be measured.
Measurements form the right heart catheterization will be recorded for analysis.
干预措施: venous plethysmography (Procedure)
Heart Failure Preserved EF
Patient prior to clinically ordered right heart catheterization identified patients will have a blood volume measurement completed in the nuclear medicine laboratory. Patients will receive an intravenous administration of low dose iodinated I-131 labeled albumin. Blood specimens (6 cc each) will be drawn at 6 minute intervals times 6. The analysis will be completed following the testing.
Venous plethysmography will be completed on eligible patients prior to the clinically indicated right heart catheterization. Calf and forearm venous compliance will be measured.
Measurements form the right heart catheterization will be recorded for analysis.
干预措施: blood volume measurement (Procedure)
Heart Failure Preserved EF
Patient prior to clinically ordered right heart catheterization identified patients will have a blood volume measurement completed in the nuclear medicine laboratory. Patients will receive an intravenous administration of low dose iodinated I-131 labeled albumin. Blood specimens (6 cc each) will be drawn at 6 minute intervals times 6. The analysis will be completed following the testing.
Venous plethysmography will be completed on eligible patients prior to the clinically indicated right heart catheterization. Calf and forearm venous compliance will be measured.
Measurements form the right heart catheterization will be recorded for analysis.
干预措施: venous plethysmography (Procedure)
结局指标
主要结局
Total Blood Volume Measurement
时间窗: Baseline prior to a clinically indicated right heart catheterization.
Blood volume will be measured at baseline for eligible patients prior to a clinical right heart catheterization.
次要结局
- venous plethysmography(Baseline prior to a clinically indicated right heart catheterization.)
研究者
Wayne L. Miller, M.D., Ph.D.
Professor of Medicine
Mayo Clinic