Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation (PURE)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 6
- 主要终点
- Composite end point of 1) patient mortality; 2) hospitalization for cardiovascular causes, including the need for i.v. diuretics and/or hemofiltration; 3) The need of increasing of ≥30% the initial daily dose of loop diuretic; 4) Worsening renal function defined as eGRF ˂10 ml/min/1,73 m2
研究概览
简要总结
Evaluate if the treatment with Peritoneal Ultrafiltration with PolyCore has an impact on the composite endpoint of patient’s mortality or worsening of patient’s condition
详细描述
The study will include adults HFrEF patients, that despite guidelines directed medical therapy still retain a congestive heart failure (HF) picture. During the study, patients should remain on their prescribed heart failure medications and the same dosing schedule for the duration of the study unless investigators determine medically necessary to change. Patients will be assigned randomly to receive either PolyCore PUF (over the top of their prescribed heart failure medications), for 6 months, or to the control arm receiving stable medical therapy according to international guidelines and comprehensive of loop diuretic (furosemide) dose till to 2.5mg/kg/day, without PUF therapy. The PUF ultrafiltration will be performed with a single nightly exchange, with 2 liters PolyCore solution, lasting 12-14 hours, for 6 months. An independent data safety monitoring board (DSMB) will be convened for this study and will review the results of the trial at regular intervals to protect patients participating in the study. An adaptive interim analysis will be performed when in each group 20 patients have completed 6 months in the study, for analysis of the primary outcome. The purpose of the adaptive interim analysis is to calculate the final study sample size.The DSMB will closely examine the interim primary efficacy results, respecting the confidentiality and integrity of data, to investigate the final sample sizes necessary to complete the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized
- 主要目的
- Long-term follow-up
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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
结局指标
主要结局
Composite end point of 1) patient mortality; 2) hospitalization for cardiovascular causes, including the need for i.v. diuretics and/or hemofiltration; 3) The need of increasing of ≥30% the initial daily dose of loop diuretic; 4) Worsening renal function defined as eGRF ˂10 ml/min/1,73 m2
Composite end point of 1) patient mortality; 2) hospitalization for cardiovascular causes, including the need for i.v. diuretics and/or hemofiltration; 3) The need of increasing of ≥30% the initial daily dose of loop diuretic; 4) Worsening renal function defined as eGRF ˂10 ml/min/1,73 m2
次要结局
- 6 min Walking distance (V1, V5, V8, V9)
- Quality of life by Kansas City Cardiomyopathy Questionnaire (V1, V5, V8, V9)
- Decrease in NT pro-BNT level of >=25% or BNP of >=40% (V1, V5, V8, V9)
- Change in NYHA class (V1, V5, V8, V9, Long term FU)
- Hospitalization for intra-venous therapy with loop diuretic
- Requiring other methods of treatment [i.e. PUF or hemodialysis]
- Hospitalization for all causes
- Worsening of renal function defined as % of change of GFR (V1, V3, V4, V5, V6, V7, V8, V9, Long term)
- Change in the cumulative daily dosage of loop diuretic
- Use of hospital resources for cardiovascular causes
- The number of patients requiring hospitalization for intra-venous therapy with loop diuretic
- The number of patients increasing of ≥30% an equivalent of the daily dose of oral furosemide
- Safety (adverse events, vital signs, physical examination, ECG, laboratory parameters)
研究者
Arduino Arduini
Scientific
Iperboreal Pharma S.r.l.