A Study of Ultra High Dose Diuretics to Treat Heart Failure

Phase 2

Completed

• Conditions: Heart Failure; With Decompensation
• Interventions: Drug: Furosemide; Drug: Bumetanide

• Registration Number: NCT06036914
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to determine the safety and effectiveness of ultrahigh dose diuretics compared to standard dose diuretics over 24 hours in patients with decompensated heart failure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Study Start: 2023-11-27
• Primary Completion: 2024-10-08
• Study Completion: 2024-10-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of decompensated heart failure receiving intravenous diuretics
• Ability to provide informed consent

Exclusion Criteria

• Patients on home inotrope medications
• Patients with Chronic Kidney disease stage V and end stage renal failure on dialysis
• Patients lacking the capacity to consent for themselves
• Known pregnancy or breastfeeding mothers
• Complex congenital heart disease
• Allergy to furosemide or bumetanide
• Respiratory failure requiring non-invasive ventilation (CPAP/BiPAP) or invasive mechanical ventilatory support at the time of randomization
• Hypotension with systolic blood pressure <80 mm Hg at the time of randomization
• Acute coronary syndrome
• Sustained Ventricular tachycardia requiring treatment in the last 48 hours
• Patients weighing ≤ 40 kg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dose diuretic group	Furosemide	Subjects with decompensated heart failure requiring hospitalization will receive IV furosemide.
Ultra-high dose diuretic group	Bumetanide	Subjects with decompensated heart failure requiring hospitalization will receive IV bumetanide.

Primary Outcome Measures

Name	Time	Method
Urine Output	24 hours	The total volume of urine produced in liters (L) over 24 hours after initiation of intravenous diuretic.

Secondary Outcome Measures

Name	Time	Method
Change in NT-proBNP	Baseline, 24 hours	Change in NT-proBNP levels (pg/ml) from Baseline to 24 hours after initiation of intravenous diuretic.
Change in Left Atrial (LA) strain	Baseline, 24 hours	LA strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Change in Peripheral Vein Pressure	Baseline, 24 hours	Peripheral vein pressure (mm Hg) will be recorded from existing IV lines through pressure transducer monitoring at Baseline and 24 hours after initiation of intravenous diuretic.
Change in Body Weight	Baseline, 24 hours	Change in Body Weight (kg) from Baseline to 24 hours after initiation of intravenous diuretic.
Change in Urine Sodium Excretion	Baseline, 24 hours	Change in amount of sodium (mmol) excreted in the urine from Baseline to 24 hours after initiation of intravenous diuretic.
Change in Right Ventricular (RV) global longitudinal strain	Baseline, 24 hours	RV global longitudinal strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Change in apnea-hypopnea index	Baseline, 24 hours	The apnea-hypopnea index (AHI) is the number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea; AHI will be measured using a Watch Pat or Nox device at Baseline and 24 hours after initiation of intravenous diuretic.
Change in Iohexol glomerular filtration rate (GFR)	Baseline, 24 hours	Renal or kidney function was measured by GFR determined by Iohexol clearance. Iohexol GFR will be measured at Baseline and 24 hours after initiation of intravenous diuretic.
Change in Cardiac Output	Baseline, 24 hours	Cardiac output (L/min) is the total volume of blood moved by the heart per minute and will be measured by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Change in estimated Right Ventricular (RV) systolic pressure	Baseline, 24 hours	Estimated RV systolic pressure (mm Hg) will be measured by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Change in Right Atrial (RA) pressure	Baseline, 24 hours	RA pressure (mm Hg) will be measured by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Change in Left Ventricular (LV) global longitudinal strain	Baseline, 24 hours	LV global longitudinal strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Change in E/e'	Baseline, 24 hours	E/e' will be assessed using echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic. It is defined as the ratio of peak early diastolic mitral inflow velocity (E) and peak early diastolic mitral annular velocity (e').

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States