TARGET: A Study to Evaluate the Treatment of Patients With Acute Decompensated Heart Failure (ADHF) Using an Automated Fluid Management System

NCT03897842 | Unknown

• 1 other identifier: TARGET0001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• 24 Hour Fluid Removal

  The primary efficacy endpoint will be the difference between target fluid loss and actual fluid loss at conclusion of therapy.

  24 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:

• Patient ≥18 years old (with body weight ≤160 kg) who is able to provide informed consent
• Subject is diagnosed and hospitalized with acute decompensated heart failure. ADHF is defined as including all of the following measured at any time between presentation and the end of screening:
• persistent dyspnea at rest or with minimal exertion at screening and at the time of enrollment, despite standard background therapy for acute heart failure including intravenous furosemide,
• Rales by chest auscultation
• 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.
• pulmonary congestion on chest radiograph
• systolic BP ≥100 mmHg at the start and at the end of screening
• Subject with pre-existing chronic renal failure (impaired renal function) defined as an eGFR between presentation and enrollment of ≥ 25 and \<90 mL/min/1.73m2, calculated using the MDRD equation.
• Subject has agreed to all follow-up testing.

You may not qualify if:

• Known inability to have a Foley catheter placed.
• Total urine output \< 200 ml or average urine rate \< 50 ml/hour in the Diuretic Challenge.
• Patient is managed on, or there is a plan to manage on, renal replacement therapy (RRT) such as ultrafiltration, hemofiltration or dialysis.
• Dyspnea due to non-cardiac causes, such as acute or chronic respiratory disorders or infections (i.e., severe chronic obstructive pulmonary disease, bronchitis, pneumonia), which may interfere with the ability to interpret the primary cause of dyspnea.
• Patients with blood pressure \> 180 mmHg at the time of enrollment or persistent heart rate \> 130 bpm.
• Temperature \>38.5°C (oral or equivalent) or sepsis or active infection requiring IV antimicrobial treatment.
• Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment. (Note: the diagnosis of acute coronary syndrome is a clinical diagnosis and that the sole presence of elevated troponin concentrations is not sufficient for a diagnosis of acute coronary syndrome, given that troponin concentrations may be significantly increased in the setting of AHF).
• 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.
• Known hepatic impairment (as evidenced by total bilirubin \> 3 mg/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 \>40 mmHg on prior or current echocardiogram) or severe mitral stenosis.
• Severe aortic insufficiency or severe mitral regurgitation for which surgical or percutaneous intervention is indicated.
• Documented, prior to or at the time of enrollment, restrictive amyloid myocardiopathy, OR acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does NOT include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).
• Current (within 2 hours prior to enrollment) or planned (through the completion of study drug infusion) treatment with any IV vasoactive therapies, including vasodilators (including nesiritide), positive inotropic agents and vasopressors, or mechanical suport (endotracheal intubation, mechanical ventilation; intra-aortic balloon pump or any ventricular assist device; hemofiltration, ultrafiltration or dialysis), with the exception of IV furosemide (or equivalent diuretic), or IV nitrates at a dose of ≤ 0.1 mg/kg/hour if the patient has a systolic BP \>150 mmHg at the start of screening.
• Any major solid organ transplant recipient or planned/ anticipated organ transplant within 1 year.

Sponsors & Collaborators

• CardioRenal Systems, Inc.: lead

Study Sites (1)

Military Hospital of Wroclaw

Wroclaw, Poland

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Andrew Halpert

CONTACT

5085418800; info@reprievecardio.com

Study Design

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

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 1, 2019
• Study Start: March 16, 2017
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: April 1, 2019

Record last verified: 2019-03

Locations

PL (1)