CTIS2024-512658-41-00进行中（未招募）1 期
Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation (PURE) - CQ-001-19
Iperboreal Pharma S.r.l.0 个研究点目标入组 84 人开始时间: 2024年4月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Adult patients, Signed informed consent form for participation in this study, Left ventricular ejection fraction =60%, NYHA Classification of III-IV, Persistency of right ventricular failure due to after load mismatch, Cava vein enlargement (between 1,5 and 2,5 cm, with respiratory collapse <50% or absent due to intravascular fluid overload), Decreased kidney function with mGFR between 15 and 60 ml/min/1.73m2, NT pro-BNP plasma concentration = 1000 pg/ml or BNP plasma concentration > 250 pg/ml, At least one episode of pulmonary or systemic congestion requiring high-dose intravenous diuretics in the 6 months before the study enrolment, Appropriate PUF technique candidate
排除标准
- •Recipients of heart transplantation, End-stage renal disease (GFR < 15ml/min/1.73m2), Any major organ transplant (liver, lung, kidney), Lung embolism = 6 months before screening, Fibrotic lung disease, Liver cirrhosis (Child B or C), Absolute contraindication to peritoneal catheter implantation, Logistical and or organizational contra-indication to treatment, Active malignancy, Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later, Female patients of childbearing age who do not use adequate contraception, Presence of a mechanical circulatory support device, Unwilling or unable to give informed consent, Enrolment in another clinical trial involving medical or device-based interventions during a) the 30 days before the screening or b) 5-times the half-life of the used investigational product, Ipersensibility to Icodextrin, L-Carnitine, D-xilitol and other PolyCore components, Evidence of any condition that, according to the investigators’ judgment, could expose the subject to undue risk and/or prevent the subject from participating in the study procedures and/or potentially affecting the study quality data, Hypertrophic obstructive cardiomyopathy, Uncontrolled hypertension with systolic blood pressure = 160 mmHg, Severe valvular stenosis, Acute coronary syndrome = 6 months before screening, Active myocarditis, Cardiosurgical or Endoradiological heart procedures = 6 month before screening, CRT implantation or upgrading of PM or ICD to CRT = 6 months before screening
研究者
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