REFORM-HF™ Reducing Fluid Overload Using Renal Independent systeM in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 13
- 主要终点
- AquaPass Performance Evaluation
研究概览
简要总结
The REFORM-HF study aims to test a new technology, AQUAPASS, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.
Patients will wear a lightweight suit that helps remove excess fluids through their sweat.
The investigators want to see if the AQUAPASS system can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics.
Participants will be treated in the hospital or in the outpatient clinic.
详细描述
This study is being conducted to demonstrate the safety and effectiveness of the AquaPass System in reducing fluid overload in patients with decompensated heart failure and chronic kidney disease stage 2-3 who are not responding adequately or resistant to current medical treatment.
The study checks if patients' fluid loss as a result of taking diuretics medications is improved when using AQUAPASS in parallel to this treatment.
The evaluation of success is done by comparing participants' weight before and after the use of the AQUAPASS system, to evaluate if the system effectively removes excess fluids.
Patients will also have blood and urine tests every morning to check how well their kidneys and heart are functioning.
The first visit will be observation only, without using AQUAPASS. This will serve as the baseline data. The investigators will compare the data of the AQUAPASS treatments with this baseline to measure the effectiveness of the system in removing excess fluids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥21 years and < 80 years
- •Subject, with known decompensated heart failure NYHA Class II, III (as evaluated by an independent observer who is not on the study team) presenting with fluid overload, defined by a congestion score of ≥3, who are not responding adequately or are resistant to current medical treatment as evidenced by persistent or worsening congestion, despite a daily dose of 80 mg furosemide or greater or the equivalent dose of another loop diuretic .
- •No change in diuretic dosage in the past 5 days
- •Subjects with eGFR between 15-89 mL/min/1.73m2
- •Baseline NT-proBNP ≥600 pg/mL
- •Baseline systolic blood pressure ≥100 mmHg
- •Subject is able and willing to provide written informed consent, inclusive of the release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation
- •Subject is not participating in any clinical investigation that may interfere with the data collection or the results of this study
排除标准
- •Subject considered to be in the acute worsening of heart failure: Requiring invasive or non-invasive mechanical ventilation, mechanical circulatory support or is clinically unstable requiring pressors, inotropes, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload .
- •Subject has any known or visible lower body (non-facial) skin condition (open wounds, ulcers, infections) that can potentially prevent using the wearable for the duration of the procedure
- •Known allergy to Polyester or Thermoplastic polyurethane (TPU)
- •Subject with severe peripheral arterial disease
- •Subject is pregnant or planning to become pregnant within the study period, or a lactating woman.
- •Subject with known hypothalamic disorders
- •Subject with known hypohidrosis disorders
- •Subjects with external medical technology dependency (gastric (G) tubes, ventilators, peripherally inserted central venous catheters, etc.)
- •Subject with cystic fibrosis
- •Subject with active infections
- •Inability or unwillingness to comply with the study requirements
- •Subjects with unstable electrolytes or acid-base balance (as per investigator's discretion)
- •Known Severe aortic valve or mitral valve stenosis
- •History of a heart transplant or actively listed for a heart transplant
- •Implanted left ventricular assist device (LVAD) or implant anticipated in <3 months
- •Subject with a life expectancy of less than 6 months, per investigator's discretion, due to malignant or non-cardiac comorbidities
研究组 & 干预措施
AquaPass
An AquaPass treatment session (up to 5-Hrs.) will be administered and supervised by certified study staff
干预措施: AquaPass System (Device)
Control
An observation visit, during which data will be collected on fluid intake, fluid output, congestion score, and body weight. These data will serve as a control for the efficacy primary endpoint comparison.
结局指标
主要结局
AquaPass Performance Evaluation
时间窗: 5 days
Average Net Fluid Loss calculated as the difference in weight between pre- and post-AquaPass treatment sessions, in comparison to the Control Day observation. Total Average Net Fluid Loss during the Treatment Phase should be ≥ 500gr. as compared to the Total Average Net Fluid Loss during the Control Phase.
AQUAPASS Performance Evaluation
时间窗: 5 days
Average Net Fluid Loss calculated as the difference in weight between pre- and post-AQUAPASS treatment sessions, in comparison to the Control Day observation. Total Average Net Fluid Loss during the Treatment Phase should be ≥ 500gr. as compared to the Total Average Net Fluid Loss during the Control Phase.
次要结局
- AquaPass Safety Evaluation(6 hours)
- AQUAPASS Safety Evaluation(6 hours)