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Congestive Heart FailureNCT03866551

Reprieve ADHF EFS IDE

A study testing Reprieve Cardiovascular System in people with Congestive Heart Failure, run by CardioRenal Systems, Inc..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Congestive Heart Failure
What is being tested?
Reprieve Cardiovascular System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
1 May 2019to 1 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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);
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  • 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.

Who cannot join

  • Candidates for participation will be ineligible for the study if any of the following exclusion criteria apply:
  • 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.
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  • 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.
  • Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (Note: restrictive mitral filling patterns noted on Transthoracic Echocardiography Assessment of diastolic function is not an exclusion).
  • Severe aortic insufficiency or severe mitral regurgitation for which surgical or percutaneous intervention is indicated.
  • Documented history of restrictive amyloid myocardiopathy, OR acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (Note: restrictive mitral filling patterns noted on Transthoracic Echocardiography Assessment of diastolic function is not an exclusion).
  • Current (within 2 hours prior to enrollment) or planned (through the completion of the Reprieve Cardiovascular System use) treatment with any IV vasoactive therapies, including vasodilators (including nesiritide), positive inotropic agents and vasopressors, or mechanical support (i.e. endotracheal intubation, mechanical ventilation; intra-aortic balloon pump or any ventricular assist device; with the exception of IV furosemide (or equivalent diuretic), IV renal dopamine <5mcg/kg/min, or IV nitrates at a dose of ≤0.1mg/kg/hour if the patient has a systolic BP >150mmHg at the start of screening.
  • Use of any investigational drugs within 30 days prior to screening.
  • Inability to follow instructions or comply with follow-up procedures.
  • Pregnant females or females anticipating pregnancy during study period.
  • Patients currently enrolled in another interventional clinical study.
  • Other concomitant disease or condition that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the protocol instructions or follow-up procedures.
  • Anuria
  • Established sensitivity to furosemide
  • Significant hypokalemia (e.g., <3.0 mEq/L)
  • Significant hypomagnesemia (e.g., <1.8 mg/dL)
  • Significant hypocalcemia (e.g., total, <7.5 mg/dL; ionized, <4.0 mg/dL)
  • Use of nephrotoxic agents (this criterion should not prevent use of nephrotoxic agents during therapy if deemed to be clinically necessary)

About this study

Official title: Reprieve Cardiovascular System for the Treatment of Subjects With Acute Decompensated Heart Failure

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.

Read the 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.

Being tested
Reprieve Cardiovascular System
Keywords
Acute Heart Failure, Decompensated Heart Failure, Heart Failure Treatment, Heart Failure Management Fluid Overload, Diuresis
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reprieve Cardiovascular SystemDevice

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

Study groups in NCT03866551
Study groupRoleWhat they receive
Interventional ArmExperimentalThe 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.
Receives: Device: Reprieve Cardiovascular System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2019
  2. Study start1 May 2019 (estimated)
  3. Primary completion1 Dec 2019 (estimated)
  4. Study completion1 Feb 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03866551
Sponsor's protocol ID
RCV-0001
Status last verified
Mar 2019
First submitted
4 Mar 2019
Last updated
7 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Reprieve Cardiovascular System in people with Congestive Heart Failure, run by CardioRenal Systems, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

72 hour fluid removal (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03866551.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019; AzTrials last refreshed its copy on 28 Oct 2026.

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