Mechanisms of Diuretic Resistance in Heart Failure, Aim 1
NCT05323487 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2026-05-22
Summary
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.
Conditions
Interventions
- DRUG
-
Bumetanide Injection
Participants in balance will present to the study site Day 0 and receive their first randomized dose of bumetanide (1.25mg, 2.5mg, 5mg, or 10mg) and undergo the bio-specimen collection protocol. They will return every 3 days, allowing 2 full days washout, to receive the other doses in random sequence.
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH -
Yale University
lead OTHER
Principal Investigators
-
Jeffrey Testani · Yale University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-01
- Primary Completion
- 2027-05-01
- Completion
- 2027-05-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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