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Completed

NCT Number: NCT06036914

A Study of Ultra High Dose Diuretics to Treat Heart Failure

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.

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Key information

Conditions

Heart Failure; With Decompensation Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Ultra-high dose diuretic

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.

Other names: Standard dose diuretic

Primary outcomes

  1. Urine Output

    Time frame: 24 hours

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

Secondary outcomes

  1. Change in Body Weight

    Time frame: Baseline, 24 hours

    Change in Body Weight (kg) from Baseline to 24 hours after initiation of intravenous diuretic.

  2. Change in NT-proBNP

    Time frame: Baseline, 24 hours

    Change in NT-proBNP levels (pg/ml) from Baseline to 24 hours after initiation of intravenous diuretic.

  3. Change in Urine Sodium Excretion

    Time frame: Baseline, 24 hours

    Change in amount of sodium (mmol) excreted in the urine from Baseline to 24 hours after initiation of intravenous diuretic.

  4. Change in Apnea-hypopnea Index

    Time frame: 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.

  5. Change in Iohexol Glomerular Filtration Rate (GFR)

    Time frame: 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.

  6. Change in Peripheral Vein Pressure

    Time frame: 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.

  7. Change in Cardiac Output

    Time frame: 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.

  8. Change in Estimated Right Ventricular (RV) Systolic Pressure

    Time frame: 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.

  9. Change in Right Atrial (RA) Pressure

    Time frame: Baseline, 24 hours

    RA pressure (mm Hg) will be measured by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.

  10. Change in Left Atrial (LA) Strain

    Time frame: Baseline, 24 hours

    LA strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.

  11. Change in Left Ventricular (LV) Global Longitudinal Strain

    Time frame: Baseline, 24 hours

    LV global longitudinal strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.

  12. Change in Right Ventricular (RV) Global Longitudinal Strain

    Time frame: Baseline, 24 hours

    RV global longitudinal strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.

  13. Change in E/e'

    Time frame: 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').

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Ultra High Dose Diuretic Strategy for Management of Acute Decompensated Heart Failure - A Randomized, Double-Blind Pilot Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2023
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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