TARGET: A Study to Evaluate the Treatment of Patients With Acute Decompensated Heart Failure (ADHF) Using an Automated Fluid Management System
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|ClinicalTrials.gov Identifier: NCT03897842|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure||Device: Reprieve Cardiovascular System||Not Applicable|
This is a prospective, single arm, early feasibility study designed to evaluate the safety and device performance of The RenalGuard System in the management of patients admitted with signs and symptoms of congestive heart failure who require diuresis for the treatment of volume overload. Subjects will be referred by their physician if he/she feels that the subject could benefit from observed diuresis in a hospital setting.
The device being utilized is called The RenalGuard® System (The System). By default, The System infuses a volume of hydration fluid equal to the volume of urine output. This is known as matched hydration. In addition, the clinician has the ability to adjust the matched setting such that RenalGuard can infuse hydration fluid to achieve a positive fluid balance (e.g. +100 ml/hr.) or a negative fluid balance (e.g. -100 ml/hr.). The purpose of this balanced fluid replacement is to prevent hypovolemia that may lead to hypotension and vital organ dysfunction, or fluid overload that may lead to shortness of breath in subjects in whom high urine output is desired.
All patients will be treated with The RenalGuard System for a minimum of 24-hours, and possibly longer, at the investigators discretion. They will be followed for 30 days post discharge. The protocol will enroll up to 40 subjects to develop the clinical algorithm required to optimally and safely perform removal of volume. The study will be conducted in up to 5 sites in Europe.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||TARGET: A Study to Evaluate the Treatment of Patients With Acute Decompensated Heart Failure (ADHF) Using an Automated Fluid Management System|
|Actual Study Start Date :||March 16, 2017|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||January 1, 2020|
Experimental: Interventional Arm
The initial phase of the study will utilize the Reprieve Cardiovascular System to support a treatment algorithm that maximizes diuretic administration while carefully monitoring patient physiologic and hemodynamic status to ensure safe decongestion.
Device: Reprieve Cardiovascular System
The Reprieve Cardiovascular System (RCS) shall be utilized to maximize fluid removal over a maximum duration of 72 hours.
- 24 Hour Fluid Removal [ Time Frame: 24 hours ]The primary efficacy endpoint will be the difference between target fluid loss and actual fluid loss at conclusion of therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897842
|Contact: Andrew Halpertemail@example.com|
|Military Hospital of Wroclaw||Recruiting|
|Contact: Cardiology +48 26 166 02 22 firstname.lastname@example.org|