Heart Failure; With DecompensationPhase 2NCT06036914
A Study of Ultra High Dose Diuretics to Treat Heart Failure
A Phase 2 study testing Bumetanide and Furosemide in people with Heart Failure; With Decompensation, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure; With Decompensation
- What is being tested?
- Bumetanide and Furosemide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to 8 Oct 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of decompensated heart failure receiving intravenous diuretics
- Ability to provide informed consent
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Ultra High Dose Diuretic Strategy for Management of Acute Decompensated Heart Failure - A Randomized, Double-Blind Pilot Trial
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
- Being tested
- Bumetanide, Furosemide
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BumetanideDrug
Also called Ultra-high dose diuretic
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.
FurosemideDrug
Also called Standard dose diuretic
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultra-high dose diuretic group | Experimental | Subjects with decompensated heart failure requiring hospitalization will receive IV bumetanide. Receives: Drug: Bumetanide |
| Standard dose diuretic group | Active comparator | Subjects with decompensated heart failure requiring hospitalization will receive IV furosemide. Receives: Drug: Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Output
The total volume of urine produced in milliliters (mL) over 24 hours after initiation of intravenous diuretic.
Measured: 24 hours
Secondary outcomes (13)
Change in Body Weight
Change in Body Weight (kg) from Baseline to 24 hours after initiation of intravenous diuretic.
Measured: Baseline, 24 hours
Change in NT-proBNP
Change in NT-proBNP levels (pg/ml) from Baseline to 24 hours after initiation of intravenous diuretic.
Measured: Baseline, 24 hours
Change in Urine Sodium Excretion
Change in amount of sodium (mmol) excreted in the urine from Baseline to 24 hours after initiation of intravenous diuretic.
Measured: Baseline, 24 hours
Change in Apnea-hypopnea Index
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.
Measured: Baseline, 24 hours
Change in Iohexol Glomerular Filtration Rate (GFR)
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.
Measured: Baseline, 24 hours
Change in Peripheral Vein Pressure
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.
Measured: Baseline, 24 hours
Change in Cardiac Output
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.
Measured: Baseline, 24 hours
Change in Estimated Right Ventricular (RV) Systolic Pressure
Estimated RV systolic pressure (mm Hg) will be measured by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Measured: Baseline, 24 hours
Change in Right Atrial (RA) Pressure
RA pressure (mm Hg) will be measured by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Measured: Baseline, 24 hours
Change in Left Atrial (LA) Strain
LA strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Measured: Baseline, 24 hours
Change in Left Ventricular (LV) Global Longitudinal Strain
LV global longitudinal strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Measured: Baseline, 24 hours
Change in Right Ventricular (RV) Global Longitudinal Strain
RV global longitudinal strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Measured: Baseline, 24 hours
Change in E/e'
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').
Measured: Baseline, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start27 Nov 2023
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Failure; With DecompensationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yogesh Reddy, Mayo Clinic
- Investigators
- Yogesh Reddy, M.B.B.S, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036914
- Sponsor's protocol ID
- 23-005262
- Status last verified
- Dec 2025
- First submitted
- 7 Sep 2023
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra High Dose Diuretic Strategy for Management of Acute Decompensated Heart Failure - A Randomized, Double-Blind Pilot Trial
- ClinicalTrials.gov ID
- NCT06036914
- Acronym / sponsor ID
- 23-005262
- Conditions
- Heart Failure; With Decompensation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Posted 14 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultra-high dose diuretic group | Experimental | Drug: BumetanideSubjects with decompensated heart failure requiring hospitalization will receive IV bumetanide. |
| Standard dose diuretic group | Active comparator | Drug: FurosemideSubjects with decompensated heart failure requiring hospitalization will receive IV furosemide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of decompensated heart failure receiving intravenous diuretics
- Ability to provide informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BumetanideAlso: Ultra-high dose diureticBumetanide 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. | Drug | Ultra-high dose diuretic group |
| FurosemideAlso: Standard dose diureticFurosemide 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. | Drug | Standard dose diuretic group |
Primary outcome
Urine Output
Time frame: 24 hours
The total volume of urine produced in milliliters (mL) over 24 hours after initiation of intravenous diuretic.
13 secondary outcomes
Change in Body Weight
Time frame: Baseline, 24 hours
Change in NT-proBNP
Time frame: Baseline, 24 hours
Change in Urine Sodium Excretion
Time frame: Baseline, 24 hours
Change in Apnea-hypopnea Index
Time frame: Baseline, 24 hours
Change in Iohexol Glomerular Filtration Rate (GFR)
Time frame: Baseline, 24 hours
Change in Peripheral Vein Pressure
Time frame: Baseline, 24 hours
Change in Cardiac Output
Time frame: Baseline, 24 hours
Change in Estimated Right Ventricular (RV) Systolic Pressure
Time frame: Baseline, 24 hours
Change in Right Atrial (RA) Pressure
Time frame: Baseline, 24 hours
Change in Left Atrial (LA) Strain
Time frame: Baseline, 24 hours
Change in Left Ventricular (LV) Global Longitudinal Strain
Time frame: Baseline, 24 hours
Change in Right Ventricular (RV) Global Longitudinal Strain
Time frame: Baseline, 24 hours
Change in E/e'
Time frame: Baseline, 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yogesh Reddy, M.B.B.S principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bumetanide and Furosemide in people with Heart Failure; With Decompensation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Output (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.