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Furosemide-induced Diuresis With Matched Dehydration Compared to Standard Diuretic Therapy in Patients With Acute Heart Failure and Overt Fluid Overload (MYTHOS-HF)

Primary Purpose

Acute Decompensated Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
RenalGuard device
Sponsored by
Centro Cardiologico Monzino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Decompensated Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: >18 years of age New York Heart Association (NYHA) functional class III or IV estimated weight gain due to peripheral fluid overload >4 kg admission BNP values >400 pg/ml if in sinus rhythm and >600 pg/ml if in atrial fibrillation Exclusion Criteria: inability to provide informed consent acute pulmonary edema, cardiogenic shock end-stage renal disease (Stage V) or need for renal replacement therapy ongoing treatment with Entresto (BNP not reliable) need for inotropic/vasopressor drug support contraindications to placement of a Foley catheter. Known hypersensitivity to furosemide

Sites / Locations

  • Centro Cardiologico Monzino, IrccsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

RenalGuard group

Arm Description

Furosemide infusion (standard treatment)

Furosemide infusion with matched de-hydration

Outcomes

Primary Outcome Measures

Daily serum creatinine measurement during study treatment for assessment of acute kidney injury occurrence
Blood sample for creatinine evaluation will be performed daily

Secondary Outcome Measures

Daily weight decrease during study treatment
Weight evaluation will be performed daily

Full Information

First Posted
February 21, 2023
Last Updated
March 28, 2023
Sponsor
Centro Cardiologico Monzino
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1. Study Identification

Unique Protocol Identification Number
NCT05807152
Brief Title
Furosemide-induced Diuresis With Matched Dehydration Compared to Standard Diuretic Therapy in Patients With Acute Heart Failure and Overt Fluid Overload
Acronym
MYTHOS-HF
Official Title
Furosemide-induced Diuresis With Matched Dehydration Compared to Standard Diuretic Therapy in Acute Heart Failure and Overt Fluid Overload
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Cardiologico Monzino

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Acute decompensated heart failure (ADHF) is a complex clinical syndrome caused by cardiac abnormalities compromising the ability of the heart to provide a blood supply adequate to the metabolic needs of peripheral tissues. ADHF is characterized by systemic and pulmonary fluid retention, with weight gain, peripheral edema, needing diuretic therapy. Moreover, ADHF is associated with neurohormonal hyper-activation with enhanced sympathetic nervous and renin-angiotensin-aldosterone systems stimulation, that sustain the vicious circle of cardiac dysfunction and fluid retention. The administration of high doses of diuretics, usually required in ADHF treatment, can induce hypovolemia-induced neurohormonal activation and transient deterioration of kidney function, that, in turn, counteracts the effect of diuretics and limits recovery from fluid overload. The investigators hypothesized that, in patients with ADHF, a more controlled and physiologically-oriented dehydration may blunt diuretic-associated neurohormonal activation, thus providing a safer and more sustained clinical benefit. This controlled dehydration can be achieved by combining furosemide with the RenalGuard System (see The RenalGuard™ System Operator's Manual for specific instructions in setting up and running the device). To date, no data have been provided regarding the potential beneficial effect of this therapeutic strategy in patients with ADHF and fluid overload. Much of the evidences on the use of the RenalGuard system comes from the clinical setting of acute kidney injury (AKI) prevention in patients undergoing intravascular contrast exposure. In this specific field, furosemide-induced high-volume diuresis with concurrent maintenance of intravascular volume through matched hydration, by the RenalGuard System, is now considered by current Guidelines a recommended strategy for AKI prevention in patients with chronic renal failure undergoing coronary interventional procedures. Based on this experience, the investigators will assess the safety and efficacy of this known system capable of delivering intravenous fluid in an amount exactly pre-determined, considering the volume of urine produced by the patient and precisely weighed by the system. This could prevent hypovolemia that may occur in response to high-volume diuresis induced by furosemide. The researchers will perform a spontaneous, prospective, randomized trial aiming at investigating the effect of combined furosemide-induced diuresis and automated matched dehydration, compared with standard furosemide administration in ADHF patients with fluid overload.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Furosemide infusion (standard treatment)
Arm Title
RenalGuard group
Arm Type
Experimental
Arm Description
Furosemide infusion with matched de-hydration
Intervention Type
Device
Intervention Name(s)
RenalGuard device
Intervention Description
Patients will be given an intravenous loading dose of 40 mg of furosemide and continuous infusion of furosemide based on baseline eGFR. An additional bolus of 40 mg of furosemide will be administered and the infusion rate increased according to the same protocol of the control group (Figure 1). The venous peripheral cannula will be connected with the extracorporeal circuit of the RenalGuard System (PLC Medical Systems Inc., MA) for fluid infusion. The RenalGuard System is capable of delivering sterile replacement solution to a patient in an amount matched, or higher or lower, to the volume of urine produced by the patient. Thus, in the RenalGuard group, estimated daily targeted negative fluid balance will be utilized to define, for each patient, hourly negative fluid balance to be set in the RenalGuard system display.
Primary Outcome Measure Information:
Title
Daily serum creatinine measurement during study treatment for assessment of acute kidney injury occurrence
Description
Blood sample for creatinine evaluation will be performed daily
Time Frame
Daily, up to 72 hours
Secondary Outcome Measure Information:
Title
Daily weight decrease during study treatment
Description
Weight evaluation will be performed daily
Time Frame
Daily, up to 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18 years of age New York Heart Association (NYHA) functional class III or IV estimated weight gain due to peripheral fluid overload >4 kg admission BNP values >400 pg/ml if in sinus rhythm and >600 pg/ml if in atrial fibrillation Exclusion Criteria: inability to provide informed consent acute pulmonary edema, cardiogenic shock end-stage renal disease (Stage V) or need for renal replacement therapy ongoing treatment with Entresto (BNP not reliable) need for inotropic/vasopressor drug support contraindications to placement of a Foley catheter. Known hypersensitivity to furosemide
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piergiuseppe Agostoni, Prof
Phone
0258002772
Email
piergiuseppe.agostoni@ccfm.it
Facility Information:
Facility Name
Centro Cardiologico Monzino, Irccs
City
Milano
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piergiuseppe Agostoni
Phone
0258002010
Email
piergiuseppe.agostoni@ccfm.it

12. IPD Sharing Statement

Learn more about this trial

Furosemide-induced Diuresis With Matched Dehydration Compared to Standard Diuretic Therapy in Patients With Acute Heart Failure and Overt Fluid Overload

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