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Recruiting Phase 1 NCT05323487

Mechanisms of Diuretic Resistance in Heart Failure, Aim 1

Trial Parameters

Condition Heart Failure
Sponsor Yale University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 75
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-06-01
Completion 2026-05-01
Interventions
Bumetanide Injection

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Clinical diagnosis of HF * No plan for titration/change of heart failure medical or device therapies during the study period. * Absence of non-elective hospitalizations in the previous 3 months. * At optimal volume status by symptoms, exam, and dry weight * Age \> 18 years Exclusion Criteria: * GFR \<20 ml/min/1.73m2 using the Chronic Kidney Disease- Epidemiology (CKD-EPI)equation or use of renal replacement therapies * Use of any non-loop type diuretic in the last 14 days with the exclusion of low dose aldosterone antagonist (e.g., spironolactone or eplerenone ≤50 mg). Examples of non-loop diuretics include but may not be limited to acetazolamide (oral or IV, not ophthalmic), metolazone, Hydrochlorothiazide (HCTZ), chlorthalidone, chlorothiazide, indapamide, triamterene, amiloride, finerenone, spironolactone dose \> 50mg day, eplerenone \> 50mg/day, * History of flash pulmonary edema requiring hospitalization and treatment with biphasic positive airway pressure o

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