Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360380
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-08
Brief Title:
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive Renal Independent System
Sponsor:
AquaPass Medical Ltd
Organization:
AquaPass Medical Ltd
Study Overview
Official Title:
REFORM-HF Reducing Fluid Overload Using Renal Independent SysteM in Heart Failure Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REFORM-HF
Brief Summary:
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 select if to be treated at their home or in the outpatient clinic
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 select if to be treated at their home or in the outpatient clinic
Detailed Description:
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 access fluids
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 access fluids
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None