A Study of Ultra High Dose Diuretics to Treat Heart Failure

NCT06036914 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 23-005262
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; With Decompensation

Outcome Measures

Primary Outcomes (1)

• Urine Output

  The total volume of urine produced in milliliters (mL) over 24 hours after initiation of intravenous diuretic.

  24 hours

Secondary Outcomes (13)

• Change in Body Weight

  Baseline, 24 hours

• Change in NT-proBNP

  Baseline, 24 hours

• Change in Urine Sodium Excretion

  Baseline, 24 hours

• Change in Apnea-hypopnea Index

  Baseline, 24 hours

• Change in Iohexol Glomerular Filtration Rate (GFR)

  Baseline, 24 hours

Study Arms (2)

Ultra-high dose diuretic group

EXPERIMENTAL

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

Drug: Bumetanide

Standard dose diuretic group

ACTIVE COMPARATOR

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

Drug: Furosemide

Interventions

Bumetanide DRUG

Bumetanide will be administered via intravenous (IV) infusion at a dose of 12.5 mg two times a day (BID) for 2 doses total within 24 hours.

Also known as: Ultra-high dose diuretic

Ultra-high dose diuretic group

Furosemide DRUG

Furosemide will be administered via intravenous (IV) infusion at usual doses (twice the home dose of oral daily diuretic in furosemide equivalents) administered as 2 doses total within 24 hours. Furosemide equivalents will be considered as follows (40 mg of intravenous furosemide = 1 mg oral bumetanide or 40 mg of torsemide or 80 mg of oral furosemide consistent with prior literature). The lowest dose of furosemide administered during the study will be 40 mg IV two times a day (BID) and the maximum dose will be 100 mg IV BID.

Also known as: Standard dose diuretic

Standard dose diuretic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Bumetanide; Furosemide; Diuretics

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Sulfanilamides; Aniline Compounds; Amines; Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Yogesh Reddy, M.B.B.S.
• Organization: Mayo Clinic

Reddy.Yogesh@mayo.edu

507-284-2904

Study Officials

• Yogesh Reddy, M.B.B.S

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: November 27, 2023
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: January 14, 2026
• Results First Posted: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)