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

NCT ID: NCT05807152

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-19
• Study Completion Date: 2024-12-31

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.

Conditions

Acute Decompensated Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

Furosemide infusion (standard treatment)

Group Type: NO_INTERVENTION

No interventions assigned to this group

RenalGuard group

Furosemide infusion with matched de-hydration

Group Type: EXPERIMENTAL

RenalGuard device

Intervention Type: DEVICE

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.

Interventions

RenalGuard device

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Cardiologico Monzino

OTHER

Sponsor Role: lead

Responsible Party

Piergiuseppe Agostoni

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Cardiologico Monzino, Irccs

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Piergiuseppe Agostoni, Prof

Role: CONTACT

piergiuseppe.agostoni@ccfm.it

0258002772

Facility Contacts

Piergiuseppe Agostoni

Role: primary

piergiuseppe.agostoni@ccfm.it

0258002010

Other Identifiers

CCM 964

Identifier Type: -

Identifier Source: org_study_id