Идёт набор NCT06360380

Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System

Без фазы С лечением Chronic Heart Failure CKD Stage 3

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: AquaPass System.
Кому может быть актуально: Состояния в реестре: Chronic Heart Failure, CKD Stage 3. Базовые параметры: 21 лет — 79 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Израиль
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

REFORM-HF™ Reducing Fluid Overload Using Renal Independent systeM in Heart Failure Patients

Обзор

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.

Подробное описание

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.

Вмешательства

Устройство AquaPass System
a treatment session of up to 5 hours with the AquaPass system, evaluating net fluid removal for efficacy analysis and effect on vital signs for safety analysis

Первичные конечные точки

AQUAPASS Performance Evaluation [Срок оценки: 5 days]

Вторичные конечные точки (1)

AQUAPASS Safety Evaluation [Срок оценки: 6 hours]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет