Chronic Heart Failure Clinical Trial
— REFORM-HF IIOfficial title:
Evaluating the Safety and Efficacy of the AquaPass System a Renal-independent Fluid Removal System in ADHF Patients Suffering From Fluid Overload. a European Registry
Verified date | May 2024 |
Source | AquaPass Medical Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The AquaPass is a non-invasive, renal-intended system designed to enhance fluid transfer through the skin, by increasing sweat rate, to treat fluid overload in heart failure patients. This study will further evaluate the safety, efficacy, and usability of the AquaPass system in the hospital and home settings.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | May 2026 |
Est. primary completion date | February 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility | Inclusion Criteria: - Subject that was hospitalized with fluid overload and a history of chronic heart failure and CKD stages 1-4 - Subject has composite congestion score =3. - Baseline systolic blood pressure at rest of =100mmHg. - Subject is capable of meeting the following study requirements: - For patients with BMI <30 kg/m2: baseline NT-pro BNP>1,600 pg/ml - For patients with BMI >30 kg/m2: baseline NT-pro BNP >800 pg/ml - For patients with rate-controlled persistent or permanent AF: NT-pro BNP >2,400 pg/ml. - Subject successfully completes 2-4 hours of run-in acclimation session - Minimal sweat rate in the last hour of run-in acclimatization of 130gr/hours Exclusion Criteria: - Subject is enrolled to another clinical investigation that might interfere with this study. - Baseline systolic blood pressure <100 mm Hg - Subject considered to be in the acute worsening of the heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrythmia, infection or other medical condition unrelated to fluid overload. - Subject has any known lower body skin problems (open wounds, ulcers) - Subject with severe peripheral arterial disease - Subject is pregnant or planning to become pregnant within the study period, or lactating mothers. - End-stage renal disease (eGFR<15 ml/min/1.73 m2) or requiring dialysis. - Inability or unwillingness to comply with the study requirements. - History of heart transplant or actively listed for heart transplant or Left Ventricular Assist Device (LVAD). - Implanted left ventricular assist device or implant anticipated <3 months. - Malignancy or other noncardiac condition limiting life expectancy to <12 months. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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AquaPass Medical Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average Sweat Rate Per Hour per patient | An average sweat rate of 150 ml/hr per patient at hospital and at home | 30 days | |
Primary | Incidence of device- and procedure-related side-effects | Incidences of system and treatment-related AEs and SAEs including symptomatic changes in vital signs | 30 days | |
Secondary | Incidence of worsening renal function | Incidence of worsening renal function, measured as an increase of Creatinine levels by >0.5mg/dL | 30 days | |
Secondary | Fluid Overload Related Hospitalizations | Hospitalization or ED visit for decompensated heart failure | 30 days | |
Secondary | Changes in congestion score | to evaluate the effect of the AquaPass treatment on congestion score | 30 days | |
Secondary | Changes in Diuretics Dose | Documentation of changes in diuretics administration to assess safety and potential benefits with system use. | 30 days | |
Secondary | Change of quality of life | Assessment of the quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The minimal score is zero '0' and the highest is '100' when higher scores represent a better outcome for the patient. | 30 days | |
Secondary | Changes in NT-ProBNP levels | Changes in NT-ProBNP levels to demonstrate the system's safety and clinical performance | 30 days | |
Secondary | Change in body weight | To evaluate the effectiveness of the AquaPass System. During the study patients will weighed before and after each treatment. The weight before the first treatment and the weight after the last treatment will be used to assess the treatment performance | 30 days |
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