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A Study of Ultra High Dose Diuretics to Treat Heart Failure

NCT ID: NCT06036914

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2024-10-08

Brief Summary

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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

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Conditions

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Heart Failure; With Decompensation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ultra-high dose diuretic group

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

Group Type EXPERIMENTAL

Bumetanide

Intervention Type 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.

Standard dose diuretic group

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

Group Type ACTIVE_COMPARATOR

Furosemide

Intervention Type 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.

Interventions

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Bumetanide

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.

Intervention Type DRUG

Furosemide

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.

Intervention Type DRUG

Other Intervention Names

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Ultra-high dose diuretic Standard dose diuretic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Yogesh Reddy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yogesh Reddy, M.B.B.S

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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23-005262

Identifier Type: -

Identifier Source: org_study_id