Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807152
Status:
RECRUITING
Last Update Posted:
2023-04-11
First Post:
2023-02-21
Brief Title:
Furosemide-induced Diuresis With Matched Dehydration Compared to Standard Diuretic Therapy in Patients With Acute Heart Failure and Overt Fluid Overload
Sponsor:
Centro Cardiologico Monzino
Organization:
Centro Cardiologico Monzino
Study Overview
Official Title:
Furosemide-induced Diuresis With Matched Dehydration Compared to Standard Diuretic Therapy in Acute Heart Failure and Overt Fluid Overload
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MYTHOS-HF
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 Operators 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
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 Operators 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None