NCT00654264已完成4 期
Water Immersion in Right-Sided Heart Failure: A Pilot Study
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Diuresis
研究概览
简要总结
This is an unblinded pilot study comparing (against a randomized control day without water immersion) the diuretic and natriuretic effects of water immersion in patients with right heart failure.
详细描述
Patients will be immersed in a tub for 3 hours (on one day) and neurohormones will be obtained before and after immersion. Urine will be collected for quantification and evaluation of sodium concentration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patients must have right sided failure secondary to right ventricular dysfunction, pulmonary hypertension, or tricuspid regurgitation
- •Age greater than 18 years of age
- •Right heart catheterization within the last year to rule out left-sided failure.
- •Evidence of fluid overload as indicated by 2 or more of the following: 1.) 2+ or more pitting edema of the lower extremities, 2.) scrotal or penile edema, 3.) JVP greater than or equal to 10 cm, 4.) abdominal ascites
排除标准
- •Pulmonary capillary wedge pressure above 16 mmHg or history of elevated left ventricular filling pressures.
- •Serum creatinine > 2.0
- •Current use of an angiotensin I converting enzyme inhibitor or angiotensin receptor blocker will preclude participation in the RAS neurohormone portion of the study.
研究组 & 干预措施
1
Other
Patients will have water immersion on first day and sitting in a tub without water on the second day.
干预措施: Water immersion (Procedure)
2
Other
Patients will sit in a tub without water on the first day and have water immersion on the second day.
干预措施: Water immersion (Procedure)
结局指标
主要结局
Diuresis
时间窗: 4 hours
次要结局
- Neurohormonal activation(4 hours)
- Natriuresis(4 hours)
研究者
Stephen Gottlieb
Professor
University of Maryland, Baltimore
研究点 (1)
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