Congestive Heart Failure
Conditions
Keywords
Acute Heart Failure, Decompensated Heart Failure, Heart Failure Treatment, Heart Failure Management Fluid Overload, Diuresis
Brief summary
This is a prospective, single arm, early feasibility study (EFS) 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.
Detailed description
This is a prospective, single arm, early feasibility study (EFS) designed to evaluate the safety and device performance of The Reprieve 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 Reprieve 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 Reprieve System for up to 72-hours, 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 the United States.
Interventions
The Reprieve Cardiovascular System (RCS) shall be utilized to maximize fluid removal over a maximum duration of 72 hours.
Sponsors
CardioRenal Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Candidates for participation in the study must meet all of the following inclusion criteria. It is anticipated that this population will include Medicare beneficiaries as the patient population is generally greater than 65 years of age: 1. Patients \> 18 years of age 2. Hospitalized with an episode of acute decompensated heart failure based on testing positive with at least two of the following: 1. Persistent dyspnea at rest or with minimal exertion despite standard background therapy for acute heart failure including treatment with furosemide; 2. Edema \> +1 on a 0-3+ scale, indicating indentation of skin with mild digital pressure that requires 10 or more seconds to resolve in any dependent area including extremities or sacral region; 3. Radiological evidence of pulmonary congestion on a chest X-ray (if an appropriate chest computerized tomography scan is done; the X-ray need not be performed); 3. Systolic BP ≥ 90 mg Hg and ≤ 180 mm Hg without the need for inotropes or vasopressors at the time of enrollment. 4. Currently receiving loop diuretics (e.g. bumetanide, torsemide, furosemide) as home therapy for a minimum of 6 months prior to admission. 5. Capable of giving written informed consent, willing to comply with study procedures 6. Females of childbearing age should use adequate contraceptives.
Exclusion criteria
Candidates for participation will be ineligible for the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 72 hour fluid removal | 72 hours | The ability to remove at least 5L of fluid and/or demonstrate clinical decongestion at completion of treatment with the Reprieve Cardiovascular System (maximum 72 hours on treatment with RCS). |
Outcome results
None listed