Congestive Heart FailureNCT03897842
TARGET: A Study to Evaluate the Treatment of Patients With Acute Decompensated Heart Failure (ADHF) Using an Automated Fluid Management System
A study testing Reprieve Cardiovascular System in people with Congestive Heart Failure, run by CardioRenal Systems, Inc. at 1 site in Poland.
Trial 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. 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
- 1 sitePoland
- Study dates
- 16 Mar 2017to 1 Jan 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
- 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
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- 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.
Who cannot join
- 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.
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- 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.
- Major surgery, including implantable devices (e.g. ICD, CRT), or major neurologic event including cerebrovascular events, within 30 days prior to screening.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a current life expectancy less than 1 year due to the malignancy.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during study treatment plus 5 days after cessation of study treatment.
- Use of any investigational drugs within 30 days prior to screening.
- Inability to follow instructions or comply with follow-up procedures.
- Any other medical condition(s) 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Military Hospital of Wroclaw
Wroclaw
Cardiology, +48 26 166 02 22, szpital@4wsk.pl
About this study
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.
Read the detailed description
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.
- Conditions
- Congestive Heart Failure
- Being tested
- Reprieve Cardiovascular System
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Reprieve Cardiovascular System |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 Hour Fluid Removal
The primary efficacy endpoint will be the difference between target fluid loss and actual fluid loss at conclusion of therapy.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start16 Mar 2017
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardioRenal Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897842
- Sponsor's protocol ID
- TARGET0001
- Status last verified
- Mar 2019
- First submitted
- 29 Mar 2019
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TARGET: A Study to Evaluate the Treatment of Patients With Acute Decompensated Heart Failure (ADHF) Using an Automated Fluid Management System
- ClinicalTrials.gov ID
- NCT03897842
- Acronym / sponsor ID
- TARGET0001
- Conditions
- Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CardioRenal Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Device: Reprieve Cardiovascular SystemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reprieve Cardiovascular SystemThe Reprieve Cardiovascular System (RCS) shall be utilized to maximize fluid removal over a maximum duration of 72 hours. | Device | Interventional Arm |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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. at 1 site in Poland.
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 9 inclusion and 22 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 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Andrew Halpert (5085418800, info@reprievecardio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 Hour Fluid Removal (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2019.