Bumetanide Injection for Heart Failure

(MsDR Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jeffrey Testani, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Yale University

Must not be taking: Non-loop diuretics

Disqualifiers: Low GFR, Flash pulmonary edema, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will employ a randomized order, double-blind, repeated measures dose ranging design. This design was chosen in order to generate multiple within-subject serial loop diuretic dose response exposures. The overall study schema will include 75 heart failure (HF) patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use non-loop diuretics in the 14 days before the study, except for low-dose aldosterone antagonists like spironolactone or eplerenone at 50 mg or less.

What data supports the effectiveness of the drug Bumetanide Injection for heart failure?

While the specific effectiveness of Bumetanide Injection for heart failure isn't directly addressed, diuretics (drugs that help remove excess fluid from the body) like Bumetanide are commonly used to manage symptoms in heart failure patients. They help reduce fluid buildup, which can ease symptoms such as swelling and shortness of breath. ^{1 2 3 4 5}

How is Bumetanide Injection unique for treating heart failure?

Bumetanide Injection is unique for treating heart failure because it is a loop diuretic (a type of medication that helps remove excess fluid from the body) administered via injection, which can provide rapid relief from fluid overload compared to oral diuretics. This can be particularly beneficial in acute settings where quick action is needed to reduce symptoms like swelling and shortness of breath. ^{6 7 8 9 10}

Research Team

Jeffrey Testani, MD

Principal Investigator

Yale University

Eligibility Criteria

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.

Inclusion Criteria

I am older than 18 years.

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

I have been diagnosed with heart failure.

Exclusion Criteria

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

Your hemoglobin level is less than 8 grams per deciliter.

I haven't taken any water pills except for low-dose spironolactone or eplerenone in the last 2 weeks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-study Diet

Participants follow a study diet provided by the metabolic kitchen to decrease variability in diuretic response

5 days

Treatment

Participants receive randomized doses of bumetanide and undergo bio-specimen collection

9 days

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bumetanide Injection (Loop Diuretic)

Trial Overview 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.

Participant Groups

Group I: Bumetanide 2.5 mg Active Control 1 Intervention

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

Group II: Bumetanide 1.25 mg Active Control 1 Intervention

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

Group III: Bumetanide 10 mg Active Control 1 Intervention

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

Group IV: Bumetanide 5 mg Active Control 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Yale University New Haven, CT

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1963

Patients Recruited

3,046,000+

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

Collaborator

Trials

2513

Patients Recruited

4,366,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication dosing in outpatients with heart failure after implementation of a practice-based performance improvement intervention: findings from IMPROVE HF. Gheorghiade, M., Albert, NM., Curtis, AB., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart Failure Due to Reduced Ejection Fraction: Medical Management. Chavey, WE., Hogikyan, RV., Van Harrison, R., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure. Packer, M., McMurray, JJ., Desai, AS., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of treatment on survival in congestive heart failure. Pitt, B., Cohn, JN., Francis, GS., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug therapy for chronic heart failure due to left ventricular systolic dysfunction: a scientific review. I. Introduction. Carneiro, AV.[2008]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal injection of corticosteroids. SIMMONS, MW.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA for the treatment of overactive bladder. Cox, L., Cameron, AP.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The First Injection: Rates of Urinary Retention in Women With Urgency Incontinence Treated With Intravesical OnabotulinumtoxinA Injection. Squires, NA., Mueller, MG., Lewicky-Gaupp, C., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Transvaginal Ultrasound-Guided BoNT-A External Sphincter Injection in Female Patients with Underactive Bladder. Tsai, CY., Yeh, YH., Tsai, LH., et al.[2023]

Ultrasound-assisted intravesical delivery of botulinum toxin A (BTX-A) using microbubbles significantly reduced bladder hyperactivity in a rat model, demonstrating its potential as a non-injection treatment method.

This method led to increased cleavage of SNAP-25 and reduced release of calcitonin gene-related peptide (CGRP), indicating a mechanism by which BTX-A can effectively alleviate symptoms of overactive bladder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-assisted intravesical botulinum toxin A delivery attenuates acetic acid-induced bladder hyperactivity in rats. Liu, Q., Gao, Y., Cong, H., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Medication dosing in outpatients with heart failure after implementation of a practice-based performance improvement intervention: findings from IMPROVE HF. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Heart Failure Due to Reduced Ejection Fraction: Medical Management. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The effect of treatment on survival in congestive heart failure. [2019]

5. Portugal pubmed.ncbi.nlm.nih.gov

Drug therapy for chronic heart failure due to left ventricular systolic dysfunction: a scientific review. I. Introduction. [2008]

6. United States pubmed.ncbi.nlm.nih.gov

Intranasal injection of corticosteroids. [2018]

7. England pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA for the treatment of overactive bladder. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The First Injection: Rates of Urinary Retention in Women With Urgency Incontinence Treated With Intravesical OnabotulinumtoxinA Injection. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy of Transvaginal Ultrasound-Guided BoNT-A External Sphincter Injection in Female Patients with Underactive Bladder. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Ultrasound-assisted intravesical botulinum toxin A delivery attenuates acetic acid-induced bladder hyperactivity in rats. [2023]