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Loop Diuretic

Bumetanide Injection for Heart Failure (MsDR Trial)

Phase 1

Recruiting

Led By Jeffrey Testani

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

No plan for titration/change of heart failure medical or device therapies during the study period

Must not have

Chronic Urinary retention limiting ability to perform timed urine collection procedures

History of flash pulmonary edema requiring hospitalization and treatment with biphasic positive airway pressure or mechanical ventilation or a "brittle" volume sensitive HF phenotype such as an infiltrative or restrictive cardiomyopathy (i.e. amyloid cardiomyopathy, etc)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 1 hour post bumetanide infusion.

Awards & highlights

Summary

This trial will study the effects of different doses of a diuretic drug on patients with heart failure who are resistant or responsive to the drug.

Who is the study for?

This trial is for adults over 18 with heart failure who are stable on their current medications and haven't been hospitalized in the last 3 months. They should not have severe kidney issues, be using certain diuretics, or have conditions like restrictive cardiomyopathy. Pregnant or breastfeeding individuals and those unable to follow the study plan are excluded.Check my eligibility

What is being tested?

The study tests how well different doses of Bumetanide Injection work in patients with heart failure. It's a controlled experiment where each patient receives multiple doses in random order without knowing which dose they're getting at any time.See study design

What are the potential side effects?

Bumetanide may cause dehydration, electrolyte imbalances (like low potassium), low blood pressure, dizziness, potential kidney problems, and could affect hearing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I am not planning to change my heart failure treatments during the study.

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I have been diagnosed with heart failure.

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I haven't been hospitalized unexpectedly in the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have chronic issues with holding urine that would prevent me from doing certain tests.

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I have been hospitalized for sudden lung swelling needing breathing support, or have a rare heart condition affecting my heart's volume.

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My kidney function is very low or I am on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in distal sodium reabsorption pre-diuretic to 1-hour post IV bumetanide infusion

Change in fractional excretion of lithium(FELi) pre-diuretic to 1-hour post IV bumetanide infusion

Ratio of A to F splice variant Messenger Ribonucleic Acid (mRNA )in urinary extracellular vesicles at baseline

+1 more

Trial Design

4Treatment groups

Active Control

Group I: Bumetanide 2.5 mgActive Control1 Intervention

2.5 mg Randomized to doses 10 mg, 5 mg, 2.5 mg, 1.25 mg

Group II: Bumetanide 1.25 mgActive Control1 Intervention

1.25 mg Randomized to doses 10 mg, 5 mg, 2.5 mg, 1.25 mg

Group III: Bumetanide 10 mgActive Control1 Intervention

Randomized to doses 10 mg, 5 mg, 2.5 mg, 1.25 mg

Group IV: Bumetanide 5 mgActive Control1 Intervention

5 mg Randomized to doses 10 mg, 5 mg, 2.5 mg, 1.25 mg

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,381 Previous Clinical Trials

4,315,027 Total Patients Enrolled

7 Trials studying Heart Failure

428 Patients Enrolled for Heart Failure

Yale UniversityLead Sponsor

1,874 Previous Clinical Trials

2,953,481 Total Patients Enrolled

33 Trials studying Heart Failure

55,934 Patients Enrolled for Heart Failure

Jeffrey TestaniPrincipal InvestigatorYale University

1 Previous Clinical Trials

50 Total Patients Enrolled

1 Trials studying Heart Failure

50 Patients Enrolled for Heart Failure

Media Library

Bumetanide Injection (Loop Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT05323487 — Phase 1

Heart Failure Research Study Groups: Bumetanide 2.5 mg, Bumetanide 1.25 mg, Bumetanide 10 mg, Bumetanide 5 mg

Heart Failure Clinical Trial 2023: Bumetanide Injection Highlights & Side Effects. Trial Name: NCT05323487 — Phase 1

Bumetanide Injection (Loop Diuretic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05323487 — Phase 1

~34 spots leftby May 2026

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