NCT04156854已完成不适用
Pathophysiologic and Outcomes Impact of the Relation of Intravascular Volume Expansion to Neuroendocrine-Renal Function Profiles in Chronic Heart Failure - Pathway to More Individualized Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in red blood cell volume
研究概览
简要总结
Researchers are trying learn more about how the heart and blood volume interact in subjects with heart failure and how measuring blood volume may help them develop better ways of treating and managing heart failure patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Acute Decompensated Chronic Heart Failure, diagnosed clinically with volume overload by the primary Heart Failure provider or Emergency Department physician and admitted to hospital.
- •New York Hear Association functional class III-IVa with stage C or D Heart Failure with Left Ventricular Ejection Fraction <50%
- •Intended treatment plan with intravenous loop diuretic therapy during hospitalization
- •Meeting none of the Exclusion Criteria
排除标准
- •Age < 18 years
- •Having received any investigational drug or device within 30 days prior to entry into the study.
- •Clinically unstable patients (e.g. systolic blood pressure < 90 mmHg, ongoing requirement for vasopressors or mechanical circulatory support, or mechanical ventilation).
- •Hospitalization within three months prior to study for hemodialysis or an ongoing requirement for hemodialysis or ultrafiltration.
- •Prior organ transplantation or being on a waiting list for organ transplantation
- •Presence of cardiac conditions such as clinically significant cardiac valve stenosis, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or primary arterial pulmonary hypertension (Group 1 PAH).
- •History of blood pressure > 190/115 mmHg or unexplained syncope within the past 3 months.
- •Symptomatic carotid artery disease, known critical carotid stenosis, or stroke within the past 3 months
- •Clinically significant intrinsic renal disease (eGFR <15 ml/min/1.72m2), renal artery stenosis, or history of fibromuscular dysplasia of the renal arteries
- •Baseline hemoglobin < 8.5 g/dl, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that is five times or more the upper limit of normal or bilirubin three times or more the upper limit of normal
- •History of alcohol abuse within the past 6 months.
结局指标
主要结局
Change in red blood cell volume
时间窗: Baseline, 1 month, 3 month, and 6 month
Measured in milliliters
Change in total blood volume
时间窗: Baseline, 1 month, 3 month, and 6 month
Measured in milliliters
Change in plasma volume
时间窗: Baseline, 1 month, 3 month, and 6 month
Measured in milliliters
次要结局
未报告次要终点
研究者
Wayne L. Miller, M.D., Ph.D.
Principal Investigator
Mayo Clinic
研究点 (2)
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