Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non-Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers
研究概览
简要总结
Ultrafiltration (UF) technology is unique for its ability to extract fluid as an isotonic solution, therefore not causing substantial changes in NaCl concentrations, and the use of peripheral veins makes it feasible to use in out of hospital medical centers, for non compensated Heart Failure (HF) with a low response to diuretics. The use of UF in the United States and Europe in out of hospital HF centers is accepted as daily practice. Therefore the hypothesis of this study is that it is feasible for a professional team to effectively use the UF for short courses on non compensated HF patients with low or no response to Diuretics, in a dedicated out of hospital HF center.
详细描述
The patients will be treated in the LIN Heart Failure Center and will not include population defined in the Exclusion criteria.
Up to 60 patients will be recruited and each one will undergo up to 30 treatments in time intervals defined by the cardiologist according to the clinical needs throughout the duration of the study.
Inclusion duration of every patient will be terminated at the end of the treatment course. No prevention in adding more treatment courses per patient according to clinical needs upon the cardiologist's decision.
Operating the UF system:
During the treatment course two of the patient's peripheral veins will be cannulated. One will be used to draw blood from, and the other will be used to return the blood back in to the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •HF patients with peripheral or pulmonic fluid retention, with little or no response to Diuretics as defined by the referring cardiologist
排除标准
- •Age < 18 years
- •Patient does not fully comprehend the Essence of the study and can not sign the informed consent.
- •Patient is participating in a drug or any other treatment study (no prevention to include patients participating in studies of non invasive monitoring technologies.
- •Presence of Acute MI
- •CR base values > 3mg/dl
- •Hemodynamic instability requiring Inotropic agents
- •HT base values > 45%
- •Known pregnancy
- •Presence of contraindication to anticoagulants
- •Post heart transplant or cardiac assist device implantation
结局指标
主要结局
Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non-Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers
时间窗: 12 months
The propose of the study is to observe the administrative needs of performing the treatment at our specific out-patient clinic. Of note the treatment is already approved including the indication and the place we are doing it so we merely aim to look at administrative and logistic that need to be done.
次要结局
未报告次要终点
研究者
Dr. Ofer Amir
Head of the Lin Heart Failure Center
Clalit Health Services