NCT02324400Unknown1 期
Pilot Study for the Evaluation of the Safety and Performance of the RenaSense System in Hospitalized Acute Decompensated Heart Failure Patients
Nephera Ltd.6 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Number of Participants with unanticipated adverse events as a measure of safety and tolerability
研究概览
简要总结
The study is intended to verify the safety and assess the performance of up to 3-days treatment protocol with the RenaSense System in ADHF patients.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years
- •Admitted to the hospital with a primary diagnosis of decompensated heart failure
- •Estimated glomerular filtration rate (GFR)* ≤60 ml/min and ≥20 ml/min, based on serum creatinine at initial evaluation
- •History of chronic use of oral loop diuretics (≥ 80 mg/day Furosemide or equivalent) during the past 3 months
- •Indication for treatment with intravenous diuretics
- •Volume overload
- •For patients with a pulmonary artery catheter, persistent volume overload will include:
- •Pulmonary capillary wedge pressure greater than 22mmHg and one of the following clinical signs:
- •at least 2+ peripheral edema and/or
- •Pulmonary edema or pleural effusions on chest x-ray
- •For patients without a pulmonary artery catheter, persistent volume overload will include at least two of the following:
- •At least 2+ peripheral edema
- •Jugular venous pressure greater than 10 cm on physical examination (or central venous pressure greater than 10 mmHg when measured)
- •pulmonary edema or pleural effusions on chest x-ray
- •Indication for urinary catheterization
- •BNP > 400 pg/mL at initial evaluation
- •Able and willing to sign the informed consent
排除标准
- •History of urinary tract infection within the last 1 month based on medical history and/or urinalysis on day of admission
- •Gross hematuria, perineal hematoma or symptomatic microscopic hematuria
- •Hypertension, systolic >180 mmHg or diastolic > 110 mmHg
- •Hypotension, systolic pressure <100 mmHg
- •Status post renal denervation
- •Implanted cardiac rhythm management device such as pacemakers, cardiac resynchronization therapy (CRT), Implantable cardioverter-defibrillator (ICD)
- •Suspected or known pregnancy
- •Previous organ transplantation
- •Life threatening condition such as severe infection, malignancy or infarction
- •Subject is participating in other concurrent clinical investigation
- •Diseases or conditions which, in the judgment of the investigator, preclude participation in the clinical trial
结局指标
主要结局
Number of Participants with unanticipated adverse events as a measure of safety and tolerability
时间窗: 72 hours
次要结局
- Renal Function as Assessed by Serum Cystatin C level(24, 48 and 72 hours)
- Sum of Global Rank Score following 72 hours of treatment as compared to baseline(72 hours)
- Urinary symptoms, hospitalizations and mortality(90 days)
- Urine volume(24, 48 and 72 hours)
研究者
研究点 (6)
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