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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,443 Previous Clinical Trials
4,331,052 Total Patients Enrolled
7 Trials studying Heart Failure
428 Patients Enrolled for Heart Failure
Yale UniversityLead Sponsor
1,920 Previous Clinical Trials
3,031,408 Total Patients Enrolled
35 Trials studying Heart Failure
58,106 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
~27 spots leftby May 2026
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