A Study of Ultra High Dose Diuretics to Treat Heart Failure

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Heart Failure; With Decompensation

Treatments: Drug: Bumetanide; Drug: Furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT06036914

23-005262

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Ultra-high dose diuretic group

Experimental group

Description:

Subjects with decompensated heart failure requiring hospitalization will receive IV bumetanide.

Treatment:

Drug: Bumetanide

Standard dose diuretic group

Active Comparator group

Description:

Subjects with decompensated heart failure requiring hospitalization will receive IV furosemide.

Treatment:

Drug: Furosemide