Reprieve ADHF EFS IDE

NCT03866551 | Unknown FDA Device

• 1 other identifier: RCV-0001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Congestive Heart Failure

Keywords

Acute Heart Failure; Decompensated Heart Failure; Heart Failure Treatment; Heart Failure Management Fluid Overload; Diuresis

Outcome Measures

Primary Outcomes (1)

• 72 hour fluid removal

  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).

  72 hours

Study Arms (1)

Interventional Arm

EXPERIMENTAL

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

Interventions

Reprieve Cardiovascular System DEVICE

The Reprieve Cardiovascular System (RCS) shall be utilized to maximize fluid removal over a maximum duration of 72 hours.

Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years of age
• Hospitalized with an episode of acute decompensated heart failure based on testing positive with at least two of the following:
• Persistent dyspnea at rest or with minimal exertion despite standard background therapy for acute heart failure including treatment with furosemide;
• 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;
• 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);
• Systolic BP ≥ 90 mg Hg and ≤ 180 mm Hg without the need for inotropes or vasopressors at the time of enrollment.
• Currently receiving loop diuretics (e.g. bumetanide, torsemide, furosemide) as home therapy for a minimum of 6 months prior to admission.
• Capable of giving written informed consent, willing to comply with study procedures
• Females of childbearing age should use adequate contraceptives.

You may not qualify if:

• Acute or suspected acute myocardial infarction (AMI) or troponin levels \> 3X the upper limit of normal at the institution's local laboratory.
• Inability to place Foley catheter or IV catheter.
• Dyspnea due to non-cardiac causes (i.e. severe chronic obstructive pulmonary disease, bronchitis, pneumonia) which may interfere with the ability to interpret the primary cause of dyspnea.
• Cardiogenic shock.
• Acute systemic infection.
• Sustained heart rate \> 130 bpm.
• AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia or atrial fibrillation/ flutter with sustained ventricular response of \>130 beats per minute; or bradycardia with sustained ventricular rate \<45 beats per minute without the use of a pacemaker.
• Patients with hemoglobin \< 8 g/dl, or a history of blood transfusion within the 14 days prior to screening, or active life-threatening GI bleeding.
• Impaired renal function based upon a GFR of \<20 ml/min/1.73m2 calculated using the aMDRD equation.
• Current or planned ultrafiltration, hemofiltration, or dialysis.
• Known hepatic impairment (as evidenced by total bilirubin \>3mg/dL, or increased ammonia levels, if performed) or history of cirrhosis with evidence of portal hypertension such as varices.
• Significant, uncorrected, left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy; or severe aortic stenosis (i.e., aortic valve area \<1.0 cm2 or mean gradient \>40mmHg on prior or current echocardiogram); or severe mitral stenosis.
• Any major solid organ transplant recipient or planned/anticipated organ transplant within 1 year.
• Major surgery or Major neurologic event, including cerebrovascular events in the 30 days.
• Severe aortic insufficiency or severe mitral regurgitation for which surgical or percutaneous intervention is indicated.

Sponsors & Collaborators

• CardioRenal Systems, Inc.: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 7, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: March 7, 2019

Record last verified: 2019-03